Early Feasibility Study of the MRace Implant for Treating Severe Mitral Regurgitation Using a Catheter-Based Delivery System in Brazil

What this Trial Is About

Researchers are evaluating the safety and feasibility of the MRace Implant and Delivery System for treating severe mitral regurgitation, a condition where the hearts mitral valve does not close properly. This early feasibility study aims to gather preliminary data on the devices performance to guide future clinical development. The study is a single-arm registry enrolling up to 10 patients at one center in Brazil. Participants will receive the MRace Implant placed on the mitral valves posterior leaflet using a catheter-based delivery system via femoral vein access and transeptal puncture. This device aims to improve valve function by augmenting the posterior leaflet. All participants will receive this study device, and the study follows them for up to 5 years after the procedure. During the study, participants will undergo evaluations including echocardiography to assess valve function and safety monitoring for mortality and major adverse events at multiple time points up to 5 years post-intervention. Researchers will measure changes in mitral regurgitation severity, technical and procedural success, and patient outcomes. Participants must commit to attending all follow-up visits for up to five years to monitor device performance and safety.

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