Clinical Trial

A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)

Study acronym: ACCESS-MR (FR)
Not Yet Recruiting
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Summary
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 20 patients at 4 centers in France.
Trial Details
NCT Number NCT07757607
Lead Sponsor Polares Medical SA
Conditions Mitral Valve (MV) Regurgitation
Enrollment 20 participants
Start Date 2026-11
Primary Completion 2032-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11