Clinical Trial

Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation

Study acronym: STAR
Not Yet Recruiting
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Summary
This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.
Trial Details
NCT Number NCT07414225
Lead Sponsor Beijing Anzhen Hospital
Conditions Atrial Functional Mitral Regurgitation
Enrollment 400 participants
Start Date 2026-02-25
Primary Completion 2030-02-25 (estimated)
Study Completion 2030-02-25 (estimated)
Updated on ClinicalTrials.gov 2026-02-17