Cardiovascular Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients (COAPT)
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.
Mitral Valve Regurgitation
Device: MitraClip System
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation|
- Primary safety endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, and any device related complications requiring non-elective cardiovascular surgery.
- Primary effectiveness endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]Recurrent heart failure (HF) hospitalizations
- Composite 30 day secondary safety endpoint [ Time Frame: 30 days post-procedure in the Device group ] [ Designated as safety issue: Yes ]Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications
- Mitral Regurgitation severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in distance walked on the 6 Minute Walk Test (6MWT distance or 6MWD) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- New York Heart Association (NYHA) Functional Class I/II [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Recurrent hospitalizations - all cause [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- All-cause mortality at 12 months and recurrent HF hospitalization (analyzed when the last subject completes 12 months of follow-up) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Freedom from all-cause mortality at 12 months will be a secondary measure of safety
- Cardiopulmonary exercise testing sub-study endpoint [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]A sub-study endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
|Experimental: Percutaneous mitral valve repair using MitraClip System||
Device: MitraClip System
Percutaneous mitral valve repair using MitraClip System
No Intervention: Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626079
|Contact: Vinod Charnani||650 firstname.lastname@example.org|
|Contact: Robin Eckert||650 email@example.com|
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|Principal Investigator:||Michael Mack, MD||Baylor Health Care System|
|Principal Investigator:||Gregg Stone, MD||Columbia University Medical Center / New York-Presbyterian Hospital|