Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
NCT ID: NCT01626079
Last Updated: 2023-11-27
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
776 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-08-31
Study Completion Date
2024-07-31
Brief Summary
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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.
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.
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.
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.
Detailed Description
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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.
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.
Conditions
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Mitral Regurgitation
Mitral Valve Regurgitation
Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects
Heart Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
614 in the Randomized Group for COAPT Trial and 162 Subjects in the COAPT CAS Group
Study Groups
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MitraClip System
Percutaneous mitral valve repair using MitraClip System
Group Type
EXPERIMENTAL
MitraClip System
Intervention Type
DEVICE
Percutaneous mitral valve repair using MitraClip System
Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Group Type
NO_INTERVENTION
No interventions assigned to this group
COAPT CAS Group
Percutaneous mitral valve repair using MitraClip System
Group Type
EXPERIMENTAL
MitraClip System
Intervention Type
DEVICE
Percutaneous mitral valve repair using MitraClip System
Interventions
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MitraClip System
Percutaneous mitral valve repair using MitraClip System
Intervention Type
DEVICE
Other Intervention Names
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MitraClip device
MitraClip
Eligibility Criteria
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Inclusion Criteria
1. 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:
1. a greater than 100% increase or greater than 50% decrease in dose of GDMT
2. 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%)
2. 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.
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
4. 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.
5. 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:
1. a greater than 100% increase or greater than 50% decrease in dose of GDMT
2. 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%).
6. 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).
7. 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.
8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory Upper Limit of Normal (ULN).
9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
10. Age 18 years or older.
11. 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.
12. 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.
13. 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.
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:
1. a greater than 100% increase or greater than 50% decrease in dose of GDMT
2. 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%)
2. 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.
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
4. 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.
5. 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:
1. a greater than 100% increase or greater than 50% decrease in dose of GDMT
2. 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%).
6. 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).
7. 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.
8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory Upper Limit of Normal (ULN).
9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
10. Age 18 years or older.
11. 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.
12. 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.
13. 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.
Exclusion Criteria
1. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
4. Percutaneous coronary intervention within 30 days prior to subject registration.
5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.
6. Tricuspid valve disease requiring surgery or transcatheter intervention.
7. Aortic valve disease requiring surgery.
8. Cerebrovascular accident within 30 days prior to subject registration.
9. Severe symptomatic carotid stenosis (\> 70% by ultrasound).
10. Carotid surgery or stenting within 30 days prior to subject registration.
11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
12. 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.
13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site.
14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
15. Mitral valve orifice area \< 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
16. 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
17. 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.
18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
19. Life expectancy \< 12 months due to non-cardiac conditions.
20. Modified Rankin Scale ≥ 4 disability.
21. Status 1 heart transplant or prior orthotopic heart transplantation.
22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
25. Active infections requiring current antibiotic therapy.
26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
28. 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.
29. 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.
30. 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.
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2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
4. Percutaneous coronary intervention within 30 days prior to subject registration.
5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.
6. Tricuspid valve disease requiring surgery or transcatheter intervention.
7. Aortic valve disease requiring surgery.
8. Cerebrovascular accident within 30 days prior to subject registration.
9. Severe symptomatic carotid stenosis (\> 70% by ultrasound).
10. Carotid surgery or stenting within 30 days prior to subject registration.
11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
12. 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.
13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site.
14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
15. Mitral valve orifice area \< 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
16. 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
17. 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.
18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
19. Life expectancy \< 12 months due to non-cardiac conditions.
20. Modified Rankin Scale ≥ 4 disability.
21. Status 1 heart transplant or prior orthotopic heart transplantation.
22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
25. Active infections requiring current antibiotic therapy.
26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
28. 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.
29. 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.
30. 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.
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Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michael Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
Gregg Stone, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
William T Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University Heart Center
JoAnn Lindenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Site Status
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, United States
Site Status
Scripps Green Hospital
La Jolla, California, United States
Site Status
Cedars-Sinai Medical Center
Los Angeles, California, United States
Site Status
El Camino Hospital
Mountain View, California, United States
Site Status
University California Davis Medical Center
Sacramento, California, United States
Site Status
Kaiser Permanente - San Francisco Hospital
San Francisco, California, United States
Site Status
Stanford Hospital and Clinics
Stanford, California, United States
Site Status
University of Colorado Hospital
Denver, Colorado, United States
Site Status
Hartford Hospital
Hartford, Connecticut, United States
Site Status
Yale - New Haven Hospital
New Haven, Connecticut, United States
Site Status
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
Morton Plant Hospital
Clearwater, Florida, United States
Site Status
Mount Sinai Medical Center
Miami, Florida, United States
Site Status
Florida Hospital Orlando
Orlando, Florida, United States
Site Status
Sarasota Memorial Hospital
Sarasota, Florida, United States
Site Status
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Site Status
Tampa General Hospital
Tampa, Florida, United States
Site Status
Piedmont Hospital Atlanta
Atlanta, Georgia, United States
Site Status
Emory University Hospital
Atlanta, Georgia, United States
Site Status
The Queen's Medical Center
Honolulu, Hawaii, United States
Site Status
Northwestern Memorial Hospital
Chicago, Illinois, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
Evanston Hospital
Evanston, Illinois, United States
Site Status
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Site Status
Iowa Heart Center
Des Moines, Iowa, United States
Site Status
University of Kansas Hosp Authority
Kansas City, Kansas, United States
Site Status
Via Christi
Wichita, Kansas, United States
Site Status
St. Joseph's Hospital - Lexington, KY
Lexington, Kentucky, United States
Site Status
Jewish Hospital
Louisville, Kentucky, United States
Site Status
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Site Status
Maine Medical Center
Portland, Maine, United States
Site Status
University of Maryland Baltimore
Baltimore, Maryland, United States
Site Status
Tufts Medical Center
Boston, Massachusetts, United States
Site Status
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Site Status
Henry Ford Hospital
Detroit, Michigan, United States
Site Status
William Beaumont Hospital
Royal Oak, Michigan, United States
Site Status
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Site Status
University of Minnesota
Minneapolis, Minnesota, United States
Site Status
Mayo Foundation for Med Edu And Research
Rochester, Minnesota, United States
Site Status
Saint Luke's Hospital
Kansas City, Missouri, United States
Site Status
Barnes Jewish Hospital
St Louis, Missouri, United States
Site Status
St. Patrick Hospital
Missoula, Montana, United States
Site Status
Nebraska Heart Institute Heart Hospital
Lincoln, Nebraska, United States
Site Status
Cooper University Hospital
Camden, New Jersey, United States
Site Status
Morristown Medical Center
Morristown, New Jersey, United States
Site Status
North Shore
Manhasset, New York, United States
Site Status
NYU Langone Medical Center
New York, New York, United States
Site Status
Mount Sinai Medical Center
New York, New York, United States
Site Status
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, United States
Site Status
NYP Weill Cornell Medical Center
New York, New York, United States
Site Status
St. Francis Hospital
Roslyn, New York, United States
Site Status
Carolinas Medical Center
Charlotte, North Carolina, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Vidant Medical Center
Greenville, North Carolina, United States
Site Status
The Christ Hospital
Cincinnati, Ohio, United States
Site Status
Cleveland Clinic
Cleveland, Ohio, United States
Site Status
Ohio State University Medical Center
Columbus, Ohio, United States
Site Status
Riverside Methodist Hospital
Columbus, Ohio, United States
Site Status
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Site Status
Providence St. Vincent Medical Center
Portland, Oregon, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
Hospital of University Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Temple University Hospital
Philadelphia, Pennsylvania, United States
Site Status
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Site Status
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
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St. Thomas Hospital
Nashville, Tennessee, United States
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Seton Medical Center Austin
Austin, Texas, United States
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Baylor Heart and Vascular Hospital
Dallas, Texas, United States
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UT Southwestern Medical Center
Dallas, Texas, United States
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Houston Methodist Hospital
Houston, Texas, United States
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Memorial Hermann Hospital
Houston, Texas, United States
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Intermountain Medical Center
Murray, Utah, United States
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University of Virginia
Charlottesville, Virginia, United States
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Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
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Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
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Swedish Medical Center Cherry Hill Campus
Seattle, Washington, United States
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St Paul's - Providence Health Care
Vancouver, British Columbia, Canada
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Hamilton Health Sciences
Hamilton, Ontario, Canada
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St Michael's Hospital
Toronto, Ontario, Canada
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Montreal Heart Institute
Montreal, Quebec, Canada
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University of Alberta
Edmonton, , Canada
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Countries
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United States
Canada
References
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Brener MI, Grayburn P, Lindenfeld J, Burkhoff D, Liu M, Zhou Z, Alu MC, Medvedofsky DA, Asch FM, Weissman NJ, Bax J, Abraham W, Mack MJ, Stone GW, Hahn RT. Right Ventricular-Pulmonary Arterial Coupling in Patients With HF Secondary MR: Analysis From the COAPT Trial. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2231-2242. doi: 10.1016/j.jcin.2021.07.047.
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Kosmidou I, Lindenfeld J, Abraham WT, Rinaldi MJ, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Gaba P, Rogers JH, Shahim B, Redfors B, Zhang Z, Mack MJ, Stone GW. Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure. JACC Heart Fail. 2021 Sep;9(9):674-683. doi: 10.1016/j.jchf.2021.04.011. Epub 2021 Aug 11.
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Arnold SV, Stone GW, Jain SS, Mack MJ, Saxon JT, Zhang Z, Lindenfeld J, Abraham WT, Cohen DJ; COAPT Investigators. Prognostic Importance of Health Status Versus Functional Status in Heart Failure and Secondary Mitral Regurgitation. JACC Heart Fail. 2021 Sep;9(9):684-692. doi: 10.1016/j.jchf.2021.04.012. Epub 2021 Aug 11.
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Shahim B, Ben-Yehuda O, Chen S, Redfors B, Madhavan MV, Kar S, Lim DS, Asch FM, Weissman NJ, Cohen DJ, Arnold SV, Liu M, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial. JACC Heart Fail. 2021 Aug;9(8):559-567. doi: 10.1016/j.jchf.2021.03.011.
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Kar S, Mack MJ, Lindenfeld J, Abraham WT, Asch FM, Weissman NJ, Enriquez-Sarano M, Lim DS, Mishell JM, Whisenant BK, Rogers JH, Arnold SV, Cohen DJ, Grayburn PA, Stone GW. Relationship Between Residual Mitral Regurgitation and Clinical and Quality-of-Life Outcomes After Transcatheter and Medical Treatments in Heart Failure: COAPT Trial. Circulation. 2021 Aug 10;144(6):426-437. doi: 10.1161/CIRCULATIONAHA.120.053061. Epub 2021 May 27.
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Gertz ZM, Herrmann HC, Lim DS, Kar S, Kapadia SR, Reed GW, Puri R, Krishnaswamy A, Gersh BJ, Weissman NJ, Asch FM, Grayburn PA, Kosmidou I, Redfors B, Zhang Z, Abraham WT, Lindenfeld J, Stone GW, Mack MJ. Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial. Circ Cardiovasc Interv. 2021 Apr;14(4):e010300. doi: 10.1161/CIRCINTERVENTIONS.120.010300. Epub 2021 Mar 15.
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Mack MJ, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant BK, Grayburn PA, Rinaldi MJ, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Rogers JH, Marx SO, Cohen DJ, Weissman NJ, Stone GW; COAPT Investigators. 3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure. J Am Coll Cardiol. 2021 Mar 2;77(8):1029-1040. doi: 10.1016/j.jacc.2020.12.047.
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Lindenfeld J, Abraham WT, Grayburn PA, Kar S, Asch FM, Lim DS, Nie H, Singhal P, Sundareswaran KS, Weissman NJ, Mack MJ, Stone GW; Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Investigators. Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial. JAMA Cardiol. 2021 Apr 1;6(4):427-436. doi: 10.1001/jamacardio.2020.7200.
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Saxon JT, Cohen DJ, Chhatriwalla AK, Kotinkaduwa LN, Kar S, Lim DS, Abraham WT, Lindenfeld J, Mack MJ, Arnold SV, Stone GW. Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: The COAPT Trial. JACC Cardiovasc Interv. 2020 Dec 14;13(23):2795-2803. doi: 10.1016/j.jcin.2020.09.023.
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Kosmidou I, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant BK, Kipperman RM, Boudoulas KD, Redfors B, Shahim B, Zhang Z, Mack MJ, Stone GW. Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial. Circ Heart Fail. 2020 Nov;13(11):e007293. doi: 10.1161/CIRCHEARTFAILURE.120.007293. Epub 2020 Nov 12.
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Giustino G, Lindenfeld J, Abraham WT, Kar S, Lim DS, Grayburn PA, Kapadia SR, Cohen DJ, Kotinkaduwa LN, Weissman NJ, Mack MJ, Stone GW. NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: The COAPT Trial. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2317-2328. doi: 10.1016/j.jcin.2020.06.058.
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Hahn RT, Asch F, Weissman NJ, Grayburn P, Kar S, Lim S, Ben-Yehuda O, Shahim B, Chen S, Liu M, Redfors B, Medvedofsky D, Puri R, Kapadia S, Sannino A, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial. J Am Coll Cardiol. 2020 Sep 15;76(11):1305-1314. doi: 10.1016/j.jacc.2020.07.035.
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Grayburn PA, Sannino A, Cohen DJ, Kar S, Lim DS, Mishell JM, Whisenant BK, Rinaldi MJ, Kapadia SR, Rajagopal V, Crowley A, Kotinkaduwa LN, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2020 Sep 1;76(9):1007-1014. doi: 10.1016/j.jacc.2020.07.010.
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Arnold SV, Stone GW, Mack MJ, Chhatriwalla AK, Austin BA, Zhang Z, Ben-Yehuda O, Kar S, Lim DS, Lindenfeld J, Abraham WT, Cohen DJ; COAPT Investigators. Health Status Changes and Outcomes in Patients With Heart Failure and Mitral Regurgitation: COAPT Trial. J Am Coll Cardiol. 2020 May 5;75(17):2099-2106. doi: 10.1016/j.jacc.2020.03.002. Epub 2020 Mar 16.
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Tang GHL. Echocardiographic Understanding of Secondary Mitral Regurgitation in Transcatheter Mitral Valve Repair: More to Learn. J Am Coll Cardiol. 2019 Dec 17;74(24):2980-2981. doi: 10.1016/j.jacc.2019.11.001. Epub 2019 Dec 9. No abstract available.
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Asch FM, Grayburn PA, Siegel RJ, Kar S, Lim DS, Zaroff JG, Mishell JM, Whisenant B, Mack MJ, Lindenfeld J, Abraham WT, Stone GW, Weissman NJ; COAPT Investigators. Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2019 Dec 17;74(24):2969-2979. doi: 10.1016/j.jacc.2019.09.017. Epub 2019 Sep 28.
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Baron SJ, Wang K, Arnold SV, Magnuson EA, Whisenant B, Brieke A, Rinaldi M, Asgar AW, Lindenfeld J, Abraham WT, Mack MJ, Stone GW, Cohen DJ; COAPT Investigators. Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial. Circulation. 2019 Dec 3;140(23):1881-1891. doi: 10.1161/CIRCULATIONAHA.119.043275. Epub 2019 Sep 29.
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Arnold SV, Chinnakondepalli KM, Spertus JA, Magnuson EA, Baron SJ, Kar S, Lim DS, Mishell JM, Abraham WT, Lindenfeld JA, Mack MJ, Stone GW, Cohen DJ; COAPT Investigators. Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation: COAPT Trial. J Am Coll Cardiol. 2019 May 7;73(17):2123-2132. doi: 10.1016/j.jacc.2019.02.010. Epub 2019 Mar 17.
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Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
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Mack MJ, Abraham WT, Lindenfeld J, Bolling SF, Feldman TE, Grayburn PA, Kapadia SR, McCarthy PM, Lim DS, Udelson JE, Zile MR, Gammie JS, Gillinov AM, Glower DD, Heimansohn DA, Suri RM, Ellis JT, Shu Y, Kar S, Weissman NJ, Stone GW. Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J. 2018 Nov;205:1-11. doi: 10.1016/j.ahj.2018.07.021. Epub 2018 Aug 1.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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11-512
Identifier Type: -
Identifier Source: org_study_id