Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial)

Summary

Participation Requirements

Description

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 loca...

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.

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