Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
COAPT
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)
1 other identifier
interventional
776
2 countries
86
Brief 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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedResults Posted
Study results publicly available
May 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedNovember 27, 2023
November 1, 2023
6.6 years
June 20, 2012
July 30, 2019
November 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
12 months
Primary Effectiveness Endpoint
Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
24 months
Secondary Outcomes (49)
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
12 months
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
12 months
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
30 days
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
12 months
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
30 days
- +44 more secondary outcomes
Other Outcomes (286)
Device or Procedure-Related Adverse Events
Within and after 30 days of the procedure
Implant Rate
Day 0
Device Procedure Time
Day 0
- +283 more other outcomes
Study Arms (3)
MitraClip System
EXPERIMENTALPercutaneous mitral valve repair using MitraClip System
Control Group
NO INTERVENTIONPatients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
COAPT CAS Group
EXPERIMENTALPercutaneous mitral valve repair using MitraClip System
Interventions
Percutaneous mitral valve repair using MitraClip System
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +7 more criteria
You may not qualify if:
- 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.
- 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)
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, 85258, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
El Camino Hospital
Mountain View, California, 94040, United States
University California Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente - San Francisco Hospital
San Francisco, California, 94115, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
University of Colorado Hospital
Denver, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale - New Haven Hospital
New Haven, Connecticut, 06510, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Mount Sinai Medical Center
Miami, Florida, 33140, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Hospital Atlanta
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Evanston Hospital
Evanston, Illinois, 60201, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Iowa Heart Center
Des Moines, Iowa, 50266, United States
University of Kansas Hosp Authority
Kansas City, Kansas, 66160, United States
Via Christi
Wichita, Kansas, 66866, United States
St. Joseph's Hospital - Lexington, KY
Lexington, Kentucky, 40504, United States
Jewish Hospital
Louisville, Kentucky, 40245, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Hospitals
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6796, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Foundation for Med Edu And Research
Rochester, Minnesota, 55905, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Patrick Hospital
Missoula, Montana, 59802, United States
Nebraska Heart Institute Heart Hospital
Lincoln, Nebraska, 68526, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
North Shore
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, 10032, United States
NYP Weill Cornell Medical Center
New York, New York, 10065, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214-3907, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hospital of University Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
St. Thomas Hospital
Nashville, Tennessee, 37205, United States
Seton Medical Center Austin
Austin, Texas, 78705, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75204, United States
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23284, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Swedish Medical Center Cherry Hill Campus
Seattle, Washington, 98122, United States
St Paul's - Providence Health Care
Vancouver, British Columbia, V6Z 1Y6, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
University of Alberta
Edmonton, Canada
Related Publications (35)
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.
PMID: 40357542DERIVEDBohra 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.
PMID: 39290680DERIVEDPio 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.
PMID: 38795108DERIVEDShahim 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.
PMID: 38788821DERIVEDCoisne 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.
PMID: 38060997DERIVEDPio 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.
PMID: 37646214DERIVEDKong 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.
PMID: 37421291DERIVEDVincent 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.
PMID: 37380226DERIVEDScotti 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.
PMID: 37306651DERIVEDLindman 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.
PMID: 37225286DERIVEDLudwig 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.
PMID: 37194288DERIVEDCox 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.
PMID: 37115135DERIVEDStone 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.
PMID: 36876756DERIVEDShahim 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.
PMID: 36752227DERIVEDGiustino 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.
PMID: 36357085DERIVEDBrener 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.
PMID: 34674862DERIVEDKosmidou 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.
PMID: 34391744DERIVEDArnold 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.
PMID: 34391740DERIVEDShahim 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.
PMID: 34325886DERIVEDKar 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.
PMID: 34039025DERIVEDGertz 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.
PMID: 33719505DERIVEDMack 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.
PMID: 33632476DERIVEDLindenfeld 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.
PMID: 33533873DERIVEDSaxon 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.
PMID: 33303119DERIVEDKosmidou 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.
PMID: 33176460DERIVEDGiustino 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.
PMID: 33092705DERIVEDHahn 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.
PMID: 32912445DERIVEDGrayburn 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.
PMID: 32854834DERIVEDArnold 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.
PMID: 32194195DERIVEDTang 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.
PMID: 31865965DERIVEDAsch 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.
PMID: 31574303DERIVEDBaron 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.
PMID: 31564137DERIVEDArnold 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.
PMID: 30894288DERIVEDStone 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.
PMID: 30280640DERIVEDMack 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.
PMID: 30134187DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sripad Bellary
- Organization
- Abbott
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Mack, MD
Baylor Health Care System
- PRINCIPAL INVESTIGATOR
Gregg Stone, MD
MOUNT SINAI HOSPITAL
- PRINCIPAL INVESTIGATOR
William T Abraham, MD
The Ohio State University Heart Center
- PRINCIPAL INVESTIGATOR
JoAnn Lindenfeld, MD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 614 in the Randomized Group for COAPT Trial and 162 Subjects in the COAPT CAS Group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2012
First Posted
June 22, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2019
Study Completion
July 1, 2024
Last Updated
November 27, 2023
Results First Posted
May 6, 2020
Record last verified: 2023-11