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Mitral RegurgitationCOAPTNCT01626079

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

A study testing MitraClip System in people with Mitral Regurgitation and Mitral Valve Regurgitation, run by Abbott Medical Devices at 86 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MitraClip System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
776 participants
Where
86 sitesin 2 countries
Study dates
Aug 2012to Jul 2024
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

  • Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.
  • Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.
  • Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after:
  • a greater than 100% increase or greater than 50% decrease in dose of GDMT
  • revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)
  • In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated.
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  • New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  • The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.
  • The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
  • Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after:
  • a greater than 100% increase or greater than 50% decrease in dose of GDMT
  • revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).
  • Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).
  • Note: The method must provide a quantitative readout (not a visual assessment).
  • The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.
  • Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).
  • Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
  • Age 18 years or older.
  • The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.
  • The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.
  • Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration.
  • For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study.
  • COAPT CAS study Inclusion Criteria:
  • 1. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Who cannot join

  • Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
  • Percutaneous coronary intervention within 30 days prior to subject registration.
  • Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.
  • Tricuspid valve disease requiring surgery or transcatheter intervention.
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  • Aortic valve disease requiring surgery.
  • Cerebrovascular accident within 30 days prior to subject registration.
  • Severe symptomatic carotid stenosis (> 70% by ultrasound).
  • Carotid surgery or stenting within 30 days prior to subject registration.
  • American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
  • Presence of any of the following:
  • Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  • Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site.
  • Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
  • Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
  • Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:
  • Insufficient mobile leaflet available for grasping with the MitraClip device
  • Evidence of calcification in the grasping area
  • Presence of a significant cleft in the grasping area
  • Lack of both primary and secondary chordal support in the grasping area
  • Leaflet mobility length < 1 cm
  • Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
  • Life expectancy < 12 months due to non-cardiac conditions.
  • Modified Rankin Scale ≥ 4 disability.
  • Status 1 heart transplant or prior orthotopic heart transplantation.
  • Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
  • Active infections requiring current antibiotic therapy.
  • Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
  • Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
  • Pregnant or planning pregnancy within next 12 months.
  • Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.
  • Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
  • For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study.
  • COAPT CAS study Exclusion Criteria:
  • 1. Subjects must not meet any of the above COAPT RCT exclusion criteria.
  • .

Trial locations and contacts

86 sites in 2 countries.

86 sites in 2 countries

United States81 sites

  • University of Michigan Hospitals

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital Atlanta

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214-3907

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75204

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • University of Colorado Hospital

    Denver, Colorado, 80045

  • Iowa Heart Center

    Des Moines, Iowa, 50266

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • University of Kansas Hosp Authority

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • St. Joseph's Hospital - Lexington, KY

    Lexington, Kentucky, 40504

  • Nebraska Heart Institute Heart Hospital

    Lincoln, Nebraska, 68526

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40245

  • North Shore

    Manhasset, New York, 11030

  • Mount Sinai Medical Center

    Miami, Florida, 33140

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • El Camino Hospital

    Mountain View, California, 94040

  • Intermountain Medical Center

    Murray, Utah, 84107

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032

  • NYP Weill Cornell Medical Center

    New York, New York, 10065

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Hospital of University Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23284

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Mayo Foundation for Med Edu And Research

    Rochester, Minnesota, 55905

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6796

  • University California Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente - San Francisco Hospital

    San Francisco, California, 94115

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Scottsdale Healthcare Hospitals

    Scottsdale, Arizona, 85258

  • Swedish Medical Center Cherry Hill Campus

    Seattle, Washington, 98122

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Via Christi

    Wichita, Kansas, 66866

  • Pinnacle Health at Harrisburg Hospital

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Canada5 sites

  • University of Alberta

    Edmonton

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St Paul's - Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects (COAPT Recruitment Closed). COAPT CAS (Recruitment Closed)

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.

Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017.

Read more

As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints)

As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.

Read the detailed description

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group).

As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study.

The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database.

COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more "real world" conditions.

COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. A total of 162 subjects were enrolled in the COAPT CAS Group.

Being tested
MitraClip System
Keywords
Functional Mitral Regurgitation, Mitral Valve Regurgitation, Symptomatic Heart Failure, Functional MR, MitraClip, Mitral Valve Insufficiency, Cardiopulmonary exercise testing, COAPT CAS, COAPT Continued Access Study, MitraClip NT
Medical subject headings
Mitral Valve Insufficiency, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitraClip SystemDevice

    Also called MitraClip device, MitraClip

    Percutaneous mitral valve repair using MitraClip System

Study groups in NCT01626079
Study groupRoleWhat they receive
MitraClip SystemExperimentalPercutaneous mitral valve repair using MitraClip System
Receives: Device: MitraClip System
Control GroupNo interventionPatients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
COAPT CAS GroupExperimentalPercutaneous mitral valve repair using MitraClip System
Receives: Device: MitraClip System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months

    Percentage of Participants with Freedom from Device related Complications at 12 Months.

    Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

    Measured: 12 months

  2. Primary Effectiveness Endpoint

    Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up

    Measured: 24 months

Secondary outcomes (49)

  1. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

    Number of recurrent Heart Failure hospitalization events at 12 months.

    Measured: 12 months

  2. New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)

    The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

    Measured: 12 months

  3. New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)

    The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

    Measured: 30 days

  4. Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physicalfunction, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possiblesubscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies thefollowing six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical FunctionDomain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQSymptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Scoreincludes total symptom and physical function scores to correspond with NYHA Classification. Overall SummaryScore includes the total symptom, physical function, social limitations and quality of life scores.

    Measured: 12 months

  5. Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

    Measured: 30 days

  6. Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)

    The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exerciseequipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of allthe systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific informationon the function of each of the different organs and systems involved in exercise or the mechanism of exerciselimitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses thesubmaximal level of functional capacity.

    Measured: 12 months

  7. Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)

    The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

    Measured: 30 days

  8. Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)

    MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

    Measured: 12 months

  9. Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)

    MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

    MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

    Measured: 30 days

  10. Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)

    Measured: 12 months

  11. Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)

    Measured: 30 days

  12. Major Vascular Complications (COAPT CAS Study Analysis)

    Measured: 12 months

  13. Major Vascular Complications (COAPT CAS Study Analysis)

    Measured: 30 days

  14. Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)

    Measured: 12 months

  15. Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)

    Measured: 30 days

  16. Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)

    Measured: 12 months

  17. Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)

    Measured: 30 days

  18. Stroke (COAPT CAS Study Analysis)

    Measured: 12 months

  19. Stroke (COAPT CAS Study Analysis)

    Measured: 30 days

  20. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 12 months

  21. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 30 days

  22. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    Measured: 12 months

  23. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    Measured: 30 days

  24. Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group

    The percentage of patients free from the composite endpoint as described above.

    Measured: 30 days post-procedure in the Device group

  25. Number of Deaths at 12 Months (All Cause Mortality)

    Death from any cause mortality at 12months.

    Measured: 12 months

  26. Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months

    MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

    MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

    Measured: 12 months

  27. Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)

    The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

    Measured: 12 months over baseline

  28. Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score.

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

    Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

    Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

    Measured: 12 months over baseline

  29. Change in Left Ventricular End Diastolic Volume (LVEDV)

    Paired data comparing the Change in LVEDV at baseline vs 12 months

    Measured: 12 months over baseline

  30. Number of Participants With New York Heart Association (NYHA) Functional Class I/II

    NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS)

    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. Patients 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

  31. Recurrent Hospitalizations - All Cause

    Number of Recurrent Hospitalizations for any cause within 24 months.

    Measured: 24 Months

  32. Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)

    The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios:

    1. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.

    Measured: 24 months

  33. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.

    Measured: 2 years

  34. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    Measured: 3 years

  35. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    Measured: 4 years

  36. Death and Primary Cause of Death (COAPT CAS Study Analysis)

    Measured: 5 years

  37. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 2 years

  38. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 3 years

  39. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 4 years

  40. Myocardial Infarction (MI) (COAPT CAS Study Analysis)

    Measured: 5 years

  41. Stroke (COAPT CAS Study Analysis)

    Measured: 2 years

  42. Stroke (COAPT CAS Study Analysis)

    Measured: 3 years

  43. Stroke (COAPT CAS Study Analysis)

    Measured: 4 years

  44. Stroke (COAPT CAS Study Analysis)

    Measured: 5 years

  45. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

    Measured: 2 years

  46. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

    Measured: 3 years

  47. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

    Measured: 4 years

  48. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

    Measured: 5 years

  49. Kaplan-Meier Freedom From All-cause Mortality

    Death from any cause within 24 months - no of events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMar 2019
  4. Study completionJul 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626079
Sponsor's protocol ID
11-512
Acronym
COAPT
Status last verified
Nov 2023
First submitted
20 Jun 2012
Last updated
27 Nov 2023
Data monitoring committee
Yes

Publications

  • Goel SS, Guha A, Lindenfeld J, Abraham WT, Kar S, Kapadia SR, Little SH, Lim DS, Reardon MJ, Kleiman NS, Aiyer J, Kotinkaduwa LN, Mack MJ, Stone GW. Impact of Natriuretic Peptide and Prior Hospitalization in Patients With Severe Mitral Regurgitation: COAPT Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015192. doi: 10.1161/CIRCINTERVENTIONS.125.015192. Epub 2025 May 13.

    PubMed 40357542

  • Bohra C, Asch FM, Lerakis S, Little SH, Redfors B, Zhou Z, Li Y, Weissman NJ, Grayburn PA, Kar S, Lim DS, Abraham WT, Lindenfeld J, Mack MJ, Bax JJ, Stone GW. Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial. Struct Heart. 2024 Jun 26;8(5):100333. doi: 10.1016/j.shj.2024.100333. eCollection 2024 Sep.

    PubMed 39290680

  • Pio SM, Medvedofsky D, Delgado V, Stassen J, Weissman NJ, Grayburn PA, Kar S, Lim DS, Redfors B, Snyder C, Zhou Z, Alu MC, Kapadia SR, Lindenfeld J, Abraham WT, Mack MJ, Asch FM, Stone GW, Bax JJ; COAPT Trial Investigators. Left Atrial Improvement in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial. JACC Cardiovasc Imaging. 2024 Sep;17(9):1015-1027. doi: 10.1016/j.jcmg.2024.03.016. Epub 2024 May 22.

    PubMed 38795108

  • Shahim B, Cohen DJ, Asch FM, Bax J, George I, Ruck A, Ben-Yehuda O, Kar S, Lim DS, Saxon JT, Zhou Z, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Repeat Mitral Valve Interventions After Transcatheter Edge-to-Edge Repair: The COAPT Trial. Am J Cardiol. 2024 Jul 15;223:7-14. doi: 10.1016/j.amjcard.2024.05.025. Epub 2024 May 23.

    PubMed 38788821

  • Coisne A, Scotti A, Granada JF, Grayburn PA, Mack MJ, Cohen DJ, Kar S, Lim DS, Lindenfeld J, Bax J, Kotinkaduwa LN, Redfors B, Weissman NJ, Asch FM, Stone GW. Regurgitant volume to LA volume ratio in patients with secondary MR: the COAPT trial. Eur Heart J Cardiovasc Imaging. 2024 Apr 30;25(5):616-625. doi: 10.1093/ehjci/jead328.

    PubMed 38060997

  • Pio SM, Medvedofsky D, Stassen J, Delgado V, Namazi F, Weissman NJ, Grayburn P, Kar S, Lim DS, Zhou Z, Alu MC, Redfors B, Kapadia S, Lindenfeld J, Abraham WT, Mack MJ, Asch FM, Stone GW, Bax JJ. Changes in Left Ventricular Global Longitudinal Strain in Patients With Heart Failure and Secondary Mitral Regurgitation: The COAPT Trial. J Am Heart Assoc. 2023 Sep 5;12(17):e029956. doi: 10.1161/JAHA.122.029956. Epub 2023 Aug 30.

    PubMed 37646214

  • Kong J, Zaroff JG, Ambrosy AP, Fitzpatrick JK, Ku IA, Mishell JM, Kotinkaduwa LN, Redfors B, Beohar N, Ailawadi G, Lindenfeld J, Abraham WT, Mack MJ, Kar S, Lim DS, Whisenant BK, Stone GW. Incidence, Predictors, and Outcomes Associated With Worsening Renal Function in Patients With Heart Failure and Secondary Mitral Regurgitation: The COAPT Trial. J Am Heart Assoc. 2023 Jul 18;12(14):e029504. doi: 10.1161/JAHA.123.029504. Epub 2023 Jul 8.

    PubMed 37421291

  • Vincent F, Redfors B, Kotinkaduwa LN, Kar S, Lim DS, Mishell JM, Whisenant BK, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial. JACC Cardiovasc Interv. 2023 Jun 26;16(12):1448-1459. doi: 10.1016/j.jcin.2023.03.023.

    PubMed 37380226

  • Scotti A, Coisne A, Granada JF, Driggin E, Madhavan MV, Zhou Z, Redfors B, Kar S, Lim DS, Cohen DJ, Lindenfeld J, Abraham WT, Mack MJ, Asch FM, Stone GW. Impact of Malnutrition in Patients With Heart Failure and Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2023 Jul 11;82(2):128-138. doi: 10.1016/j.jacc.2023.04.047. Epub 2023 Jun 9.

    PubMed 37306651

  • Lindman BR, Asch FM, Grayburn PA, Mack MJ, Bax JJ, Gonzales H, Goel K, Barker CM, Zalawadiya SK, Zhou Z, Alu MC, Weissman NJ, Abraham WT, Lindenfeld J, Stone GW. Ventricular Remodeling and Outcomes After Mitral Transcatheter Edge-to-Edge Repair in Heart Failure: The COAPT Trial. JACC Cardiovasc Interv. 2023 May 22;16(10):1160-1172. doi: 10.1016/j.jcin.2023.02.031.

    PubMed 37225286

  • Ludwig S, Conradi L, Cohen DJ, Coisne A, Scotti A, Abraham WT, Ben Ali W, Zhou Z, Li Y, Kar S, Duncan A, Lim DS, Adamo M, Redfors B, Muller DWM, Webb JG, Petronio AS, Ruge H, Nickenig G, Sondergaard L, Adam M, Regazzoli D, Garatti A, Schmidt T, Andreas M, Dahle G, Walther T, Kempfert J, Tang GHL, Redwood S, Taramasso M, Praz F, Fam N, Dumonteil N, Obadia JF, von Bardeleben RS, Rudolph TK, Reardon MJ, Metra M, Denti P, Mack MJ, Hausleiter J, Asch FM, Latib A, Lindenfeld J, Modine T, Stone GW, Granada JF; CHOICE-MI and the COAPT Trial Investigators. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison. Circ Cardiovasc Interv. 2023 Jun;16(6):e013045. doi: 10.1161/CIRCINTERVENTIONS.123.013045. Epub 2023 May 16.

    PubMed 37194288

  • Cox ZL, Zalawadiya SK, Simonato M, Redfors B, Zhou Z, Kotinkaduwa L, Zile MR, Udelson JE, Lim DS, Grayburn PA, Mack MJ, Abraham WT, Stone GW, Lindenfeld J. Guideline-Directed Medical Therapy Tolerability in Patients With Heart Failure and Mitral Regurgitation: The COAPT Trial. JACC Heart Fail. 2023 Jul;11(7):791-805. doi: 10.1016/j.jchf.2023.03.009. Epub 2023 Apr 26.

    PubMed 37115135

  • Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.

    PubMed 36876756

  • Shahim B, Cohen DJ, Ben-Yehuda O, Redfors B, Kar S, Lim DS, Arnold SV, Li Y, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Impact of Peripheral Artery Disease in Patients With Heart Failure Undergoing Transcatheter Mitral Valve Repair: The COAPT Trial. J Am Heart Assoc. 2023 Feb 21;12(4):e028444. doi: 10.1161/JAHA.122.028444. Epub 2023 Feb 8.

    PubMed 36752227

  • Giustino G, Camaj A, Kapadia SR, Kar S, Abraham WT, Lindenfeld J, Lim DS, Grayburn PA, Cohen DJ, Redfors B, Zhou Z, Pocock SJ, Asch FM, Mack MJ, Stone GW. Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial. J Am Coll Cardiol. 2022 Nov 15;80(20):1857-1868. doi: 10.1016/j.jacc.2022.08.803.

    PubMed 36357085

Questions about this trial

What is this clinical trial studying?

A study testing MitraClip System in people with Mitral Regurgitation and Mitral Valve Regurgitation, run by Abbott Medical Devices at 86 sites in 2 countries.

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 24 inclusion and 44 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada. 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 6 May 2020). 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?

Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months (time frame: 12 months). The study lists 2 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 NCT01626079, which also lists 35 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 27 Nov 2023.

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