Clinical Trial

MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry

Study acronym: MITRAGEN5
Not Yet Recruiting
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Summary
The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-28
Trial Details
NCT Number NCT07543874
Lead Sponsor University Hospital of Cologne
Collaborators: Montefiore Medical Center, Cardiovascular Research Foundation, New York
Conditions Mitral Regurgitation
Enrollment 1,000 participants
Start Date 2026-05-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-01