COAPT Trial: MitraClip® for Leaky Heart Valve
The purpose of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) 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.
A subset of patients will be registered in a cardiopulmonary exercise sub-study (CPX); the objective is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive the MitraClip device (the device group) compared with the control group who do not receive the device.
A subset of patients will be registered in a cardiopulmonary exercise sub-study (CPX); the objective is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive the MitraClip device (the device group) compared with the control group who do not receive the device.
Desired Outcome Measures
The primary, secondary and other outcome measures are defined as follows.
- The primary desired outcome measure will be to determine primary safety and effectiveness endpoints.
- The secondary and additional desired outcome measures are numerous; you can read them in detail here .
Basic Criteria for Participants
The basic criteria for participants in this study are that you be 18 years old or older and have symptomatic functional mitral regurgitation (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology.
To learn more about the COAPT Trial, go to clinicaltrials.gov or contact our Study Coordinator.
Pam Hazen
Clinical Research Coordinator IIPam Hazen
Office: 713-441-9716
Pager: 713-606-4720
phazen@houstonmethodist.org
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