Aortic Valve StenosisTRANSFORM™NCT01700439
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
A study testing EDWARDS INTUITY valve in people with Aortic Valve Stenosis and Aortic Valve Stenosis With Insufficiency, run by Edwards Lifesciences at 29 sites in United States.
Trial summary
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve
- What is being tested?
- EDWARDS INTUITY valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 934 participants
- Where
- 29 sitesUnited States
- Study dates
- 26 Sep 2012to 26 May 2021
- 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
- Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
- Male or female, age 18 years or older
- Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation
- Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
- Provide written informed consent
- Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up
Who cannot join
- Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
- Pure aortic insufficiency
- Requires emergency surgery
- Previous aortic valve replacement
- Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
- Requires multiple valve replacement/repair
Show all 32Show fewer
- Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
- Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
- Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
- Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
- Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
- Hyperparathyroidism
- MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
- Presence of non-cardiac disease limiting life expectancy to less than 12 months
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Left ventricular ejection fraction ≤ 25%
- Documented history of substance (drug or alcohol) abuse within the last 5 years
- Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
- Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
- Pregnancy, lactation, or planning to become pregnant;
- Currently incarcerated or unable to give voluntary informed consent
- Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
- History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
- Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
- Intra-operative Exclusion Criteria
- Anatomic variances which contraindicate implant of the trial valve, such as:
- anomalous coronary arteries
- annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
- significant calcium on the anterior mitral leaflet
- pronounced septal calcification
- position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
- Available devices are not suitably sized for the subject's annulus
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
The University of Michigan Medical School
Ann Arbor, Michigan, 48109
Mission Hospital
Asheville, North Carolina, 28801
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper University Hospital
Camden, New Jersey, 08103
Northwestern University
Chicago, Illinois, 60611
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Medical City Dallas Hospital
Dallas, Texas, 75230
Duke University Medical Center
Durham, North Carolina, 27705
East Carolina University
Greenville, North Carolina, 27834
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17010
Baylor College of Medicine
Houston, Texas, 77030
Keck Hospital of University of Southern California
Los Angeles, California, 90033
University of California Los Angeles
Los Angeles, California, 90095
North Shore Long Island Jewish Health System
Manhasset, New York, 11030
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215
St. Thomas Health
Nashville, Tennessee, 37205
New York University Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Florida Hospital
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Mercy General Hospital
Sacramento, California, 95819
Swedish Medical Center
Seattle, Washington, 98122
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Read the detailed description
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Being tested
- EDWARDS INTUITY valve
- Keywords
- Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery, Aortic valve stenosis, Aortic valve regurgitation, Bovine pericardium
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDWARDS INTUITY valveDevice
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
| Study group | Role | What they receive |
|---|---|---|
| EDWARDS INTUITY valve | Experimental | All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System. Receives: Device: EDWARDS INTUITY valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
Measured: Events occurring ≥ 31 days and up through 8 years post-implant
Secondary outcomes (14)
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
Measured: Day of procedure
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
Measured: Day of procedure through discharge or 10 days post index procedure, whichever comes first.
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Surgical and hospitalization factors - Cardiopulmonary bypass time
Measured: Day of procedure
Average Subject Time on Cardiopulmonary Cross Clamp
Surgical and hospitalization factors - Cardiopulmonary cross clamp time
Measured: Day of procedure
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
Measured: Day of procedure through discharge from the hospital
Subject's New York Heart Association (NYHA) Classification Over Time
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Measured: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
Subject's Average Mean Gradient Measurements Over Time
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Subject's Average Peak Gradient Measurements Over Time
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Subject's Effective Orifice Area (EOA) Measurement Over Time
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Performance Index Measurement Over Time
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Cardiac Output Measurement at Over Time
Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Cardiac Index Measurement Over Time
Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
Measured: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study start26 Sep 2012
- Primary completion26 May 2021
- Study completion26 May 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Barnhart, MD, Principal investigator, Swedish Medical CenterWalter Randolph Chitwood, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700439
- Sponsor's protocol ID
- 2011-02
- Acronym
- TRANSFORM™
- Status last verified
- May 2023
- First submitted
- 19 Sep 2012
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
PubMed 27817951Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.
PubMed 29705366
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
- ClinicalTrials.gov ID
- NCT01700439
- Acronym / sponsor ID
- TRANSFORM™ / 2011-02
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Keywords
- Aortic valve, Heart valve, Tissue valve, Bioprosthesis, Valve disorder, Valve disease, Cardiac surgery, Less invasive cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2012 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Detailed description
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDWARDS INTUITY valve | Experimental | Device: EDWARDS INTUITY valveAll subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
Key exclusion criteria (32 listed)
- Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
- Pure aortic insufficiency
- Requires emergency surgery
- Previous aortic valve replacement
- Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
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 |
|---|---|---|
| EDWARDS INTUITY valveSurgical replacement of the aortic valve with the EDWARDS INTUITY valve. | Device | EDWARDS INTUITY valve |
Primary outcome
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
Time frame: Events occurring ≥ 31 days and up through 8 years post-implant
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
14 secondary outcomes
Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Time frame: Day of procedure
Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Time frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first.
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Time frame: Day of procedure
Average Subject Time on Cardiopulmonary Cross Clamp
Time frame: Day of procedure
Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Time frame: Day of procedure through discharge from the hospital
Subject's New York Heart Association (NYHA) Classification Over Time
Time frame: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
Subject's Average Mean Gradient Measurements Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Subject's Average Peak Gradient Measurements Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
Subject's Effective Orifice Area (EOA) Measurement Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Performance Index Measurement Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Cardiac Output Measurement at Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Subject's Cardiac Index Measurement Over Time
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27817951Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
- Results publication: PubMed 29705366Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Glenn Barnhart, MD principal investigator
Swedish Medical Center
Walter Randolph Chitwood, MD principal investigator
East Carolina University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDWARDS INTUITY valve in people with Aortic Valve Stenosis and Aortic Valve Stenosis With Insufficiency, run by Edwards Lifesciences at 29 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 6 inclusion and 32 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 13 Dec 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 Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort (time frame: Events occurring ≥ 31 days and up through 8 years post-implant). 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 NCT01700439, which also lists 2 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 19 May 2023.