EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant

An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary 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 10 patients at one (1) center in Brazil.

NCT Number	NCT06113354
Lead Sponsor	Polares Medical SA Collaborators: Polares Medical, Inc.
Conditions	Mitral Valve Disease
Enrollment	10 participants
Start Date	2024-04-08
Primary Completion	2032-12 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-10