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

Study acronym: STAR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment openedv2 Show 4 more changesShow less
    • Start date changed from estimate of Feb 25, 2026 to Jun 1, 2026
    • Interventions modified
    • Eligibility criteria expanded, about 11 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)
Atrial Functional Mitral Regurgitation
Related terms Atrial Fibrillation, Mitral Valve Insufficiency
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov