RecruitingNot ApplicableNCT06113354

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

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

Sponsor

Polares Medical SA

Enrollment

10 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Disease

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transcatheter mitral valve repair (MRace Implant and Delivery System) for people with mitral valve disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscatheter mitral valve repair (MRace Implant and Delivery System)

The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture Other Names: TMVr