Mitral Valve InsufficiencyREALISMNCT01931956
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
A study testing MitraClip® implant in people with Mitral Valve Insufficiency and Mitral Valve Regurgitation, run by Abbott Medical Devices at 38 sites in United States.
Trial summary
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence
- What is being tested?
- MitraClip® implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 965 participants
- Where
- 38 sitesUnited States
- Study dates
- 22 Jan 2009to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
- Male or non-pregnant female
- Trans-septal catheterization is determined to be feasible by the treating physician
- High Risk Arm:
- Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:
- Porcelain aorta or mobile ascending aortic atheroma
Show all 20Show fewer
- Post-radiation mediastinum
- Previous mediastinitis
- Functional MR with EF <40
- Over 75 years old with EF<40
- Re-operation with patent grafts
- Two or more prior chest surgeries
- Hepatic cirrhosis
- Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35
- Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
- American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower
- Non-High Risk Arm:
- Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:
- 1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise
- Candidate for MV repair or replacement surgery, including cardiopulmonary bypass
Who cannot join
- Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
- In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
- MV orifice area <4.0 cm2
- If leaflet flail is present:
- Flail Width ≥15 mm, or
- Flail Gap ≥10 mm.
Show all 36Show fewer
- If leaflet tethering is present:
- 1. Vertical coaptation length <2 mm
- Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
- Evidence of calcification in the grasping area of the A2 and/or P2 scallops
- Presence of a significant cleft of A2 or P2 scallops
- More than one anatomic criteria dimensionally near the exclusion limits
- Bileaflet flail or severe bileaflet prolapse
- Lack of both primary and secondary chordal support
- Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
- Need for emergency surgery for any reason
- Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
- History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
- Life expectancy <12 months
- Active infections requiring current antibiotic therapy
- Patients in whom transesophageal echocardiography (TEE) is contraindicated
- High Risk Arm:
- EF <20%, and/or LVESD >60 mm
- Non-High Risk Arm:
- The need for any other cardiac surgery
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
- Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm)
- Severe mitral annular calcification
- Systolic anterior motion of the MV leaflet
- Hypertrophic cardiomyopathy
- History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
- Upper GI bleeding within the prior 6 months
- Platelet count <75,000 cells/mm³
- Creatinine >2.5mg/dL
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Piedmont Hospital
Atlanta, Georgia, 30309
St. Joseph's Hospital
Atlanta, Georgia, 30342
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolina's Medical Center (Sanger Clinic)
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22903
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75226
Duke University Medical Center
Durham, North Carolina, 27710
Evanston Hospital
Evanston, Illinois, 60201
East Carolina Heart Institute
Greenville, North Carolina, 27834
Terrebonne General Medical Center
Houma, Louisiana, 70360
Memorial Hermann Hospital
Houston, Texas, 77024
The Care Group Medical Center (St. Vincent Hospital)
Indianapolis, Indiana, 46290
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Baptist Hospital of Miami, FL
Miami, Florida, 33176
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
St. Patrick's Hospital & Health Science Center
Missoula, Montana, 59802
Morristown Memorial Hospital
Morristown, New Jersey, 07960
El Camino Hospital
Mountain View, California, 94040
Intermountain Medical Center
Murray, Utah, 84107
New York University Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
St. Francis Hospital
Roslyn, New York, 11576
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California Davis Medical Center
Sacramento, California, 95817
University of Texas Health Science Center
San Antonio, Texas, 78229
Swedish Medical Center
Seattle, Washington, 98122
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204
Washington University School of Medicine
St Louis, Missouri, 63110
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).
Read the detailed description
The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.
REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
- Being tested
- MitraClip® implant
- Keywords
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, Mitral Regurgitation (MR), Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, Coronary Artery Disease (CAD), Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Coronary Artery Disease, Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip® implantDevice
Percutaneous mitral valve repair using MitraClip implant
| Study group | Role | What they receive |
|---|---|---|
| Non-High Risk | Experimental | Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274. Receives: Device: MitraClip® implant |
| High Risk | Experimental | Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120. Receives: Device: MitraClip® implant |
| Compassionate Use | Experimental | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. Receives: Device: MitraClip® implant |
| Emergency Use | Experimental | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. Receives: Device: MitraClip® implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Adverse Events
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Measured: 30 days
Number of Participants With Major Adverse Events
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Measured: 12 months
Number of Participants With 12-Month Efficacy
Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).
Measured: 12 months
Secondary outcomes (81)
Number of Participants With Serious Adverse Events
The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.
Measured: 30 days
Number of Participants With Serious Adverse Events
The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.
Measured: 12 months
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Measured: 30 days
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Measured: 12 months
Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 30 days
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 12 Months
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 2 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 3 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 4 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Measured: 5 years
Number of Participants With Acute Procedural Success
Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure)
Number of Participants With Procedural Success
Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.
Measured: 30 days
Number of Participants With Clinical Durability
Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.
Measured: 12 months
Number of Participants With Clip Implant Rate
Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.
Measured: On the day of index procedure (≤1 day)
Procedure Time
The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.
Measured: On the day of index procedure
Device Time
Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.
Measured: On the day of index procedure
Fluoroscopy Duration
Mean fluoroscopy duration during the MitraClip procedure.
Measured: On the day of index procedure
Number of Participants With MitraClip Devices Implanted
The distribution of number of MitraClip devices implanted in patients.
Measured: On the day of index procedure
Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration
Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure).
Post-Procedure Length of Hospital Stay
Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure).
Number of Participants Experiencing Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 12 months visit window (410 days)
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility
Measured: At discharge (an average of ≤ 12.3 days post-index procedure)
Number of Participants With Hospital Re-admissions
Defined as re-admission of patients to the hospital following discharge from the Clip procedure.
Measured: 30 days
Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 0 to 5 years
Number of Participants With Mitral Stenosis
Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL).
Measured: 0 to 5 years
Number of Participants With Mitral Regurgitation (MR) Severity
Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography.
MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 30 days(Follow-up)
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 12 months
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 2 years
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 3 years
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 4 years
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 5 years
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.
Measured: 139 days post the index procedure
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.
Measured: 5 years
Number of Participants With New York Heart Association (NYHA) Functional Class
Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 30 days
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 12 months
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 2 years
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 3 years
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 4 years
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 5 years
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.
Measured: 48 months
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.
Measured: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.
Measured: 12 months
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.
Measured: 24 months
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.
Measured: 36 months
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.
Measured: 48 months
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start22 Jan 2009
- Primary completionFeb 2015
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ted Feldman, M.D. Feldman, M.D., Study director, Endeavor HealthDonald D Glower Jr., MD, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931956
- Sponsor's protocol ID
- 0401B
- Other IDs
- 0401
- Acronym
- REALISM
- Status last verified
- Nov 2018
- First submitted
- 27 Aug 2013
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
PubMed 21741608Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
PubMed 23608290Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.
PubMed 25011722Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
PubMed 30586701Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
PubMed 25593120Lim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014 Jul 15;64(2):182-92. doi: 10.1016/j.jacc.2013.10.021. Epub 2013 Oct 31.
PubMed 24184254
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)
- ClinicalTrials.gov ID
- NCT01931956
- Acronym / sponsor ID
- REALISM / 0401B
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
- Keywords
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, Mitral Regurgitation (MR), Mitral Valve Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 965 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2009 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).
Detailed description
The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.
REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-High Risk | Experimental | Device: MitraClip® implantIncludes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274. |
| High Risk | Experimental | Device: MitraClip® implantIncludes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120. |
| Compassionate Use | Experimental | Device: MitraClip® implantPatients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
| Emergency Use | Experimental | Device: MitraClip® implantPatients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
- Male or non-pregnant female
- Trans-septal catheterization is determined to be feasible by the treating physician
- Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:
- Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
Key exclusion criteria (36 listed)
- Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
- In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
- MV orifice area <4.0 cm2
- If leaflet flail is present:
- If leaflet tethering is present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip® implantPercutaneous mitral valve repair using MitraClip implant | Device | Compassionate Use, Emergency Use, High Risk, Non-High Risk |
Primary outcome
Number of Participants With Major Adverse Events
Time frame: 30 days
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Number of Participants With Major Adverse Events
Time frame: 12 months
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Number of Participants With 12-Month Efficacy
Time frame: 12 months
Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).
81 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: 30 days
Number of Participants With Serious Adverse Events
Time frame: 12 months
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Time frame: 30 days
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Time frame: 12 months
Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age
Time frame: 30 days
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
Time frame: 12 Months
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
Time frame: 2 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
Time frame: 3 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
Time frame: 4 years
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
Time frame: 5 years
Number of Participants With Acute Procedural Success
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)
Number of Participants With Procedural Success
Time frame: 30 days
Number of Participants With Clinical Durability
Time frame: 12 months
Number of Participants With Clip Implant Rate
Time frame: On the day of index procedure (≤1 day)
Procedure Time
Time frame: On the day of index procedure
Device Time
Time frame: On the day of index procedure
Fluoroscopy Duration
Time frame: On the day of index procedure
Number of Participants With MitraClip Devices Implanted
Time frame: On the day of index procedure
Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).
Post-Procedure Length of Hospital Stay
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).
Number of Participants Experiencing Death
Time frame: 12 months visit window (410 days)
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)
Number of Participants With Hospital Re-admissions
Time frame: 30 days
Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)
Time frame: 0 to 5 years
Number of Participants With Mitral Stenosis
Time frame: 0 to 5 years
Number of Participants With Mitral Regurgitation (MR) Severity
Time frame: 30 days(Follow-up)
Number of Participants With MR Severity
Time frame: 12 months
Number of Participants With MR Severity
Time frame: 2 years
Number of Participants With MR Severity
Time frame: 3 years
Number of Participants With MR Severity
Time frame: 4 years
Number of Participants With MR Severity
Time frame: 5 years
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
Time frame: 139 days post the index procedure
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
Time frame: 5 years
Number of Participants With New York Heart Association (NYHA) Functional Class
Time frame: 30 days
Number of Participants With NYHA Functional Class
Time frame: 12 months
Number of Participants With NYHA Functional Class
Time frame: 2 years
Number of Participants With NYHA Functional Class
Time frame: 3 years
Number of Participants With NYHA Functional Class
Time frame: 4 years
Number of Participants With NYHA Functional Class
Time frame: 5 years
Left Ventricular End-diastolic Volume (LVEDV)
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21741608Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
- Results publication: PubMed 23608290Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
- Results publication: PubMed 25011722Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.
- Derived from this study: PubMed 30586701Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
- Derived from this study: PubMed 25593120Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
- Derived from this study: PubMed 24184254Lim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014 Jul 15;64(2):182-92. doi: 10.1016/j.jacc.2013.10.021. Epub 2013 Oct 31.
- Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatmentsLink provided by the sponsor.
Related trials for Mitral Valve Insufficiency
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Feldman, M.D. Feldman, M.D. study director
Endeavor Health
Donald D Glower Jr., MD study director
Duke University
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraClip® implant in people with Mitral Valve Insufficiency and Mitral Valve Regurgitation, run by Abbott Medical Devices at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Major Adverse Events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931956, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.