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 (AU)

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 15 patients at 1 center in Australia

NCT Number	NCT07757698
Lead Sponsor	Polares Medical SA
Conditions	Mitral Valve (MV) Regurgitation
Enrollment	15 participants
Start Date	2026-11
Primary Completion	2032-12 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-11