RecruitingNot ApplicableNCT07517588

EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)


Sponsor

Polares Medical SA

Enrollment

15 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called MR-ace Implant and Delivery System for people with mitral regurgitation. The study is currently recruiting participants at 3 locations.

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

DEVICEMR-ace Implant and Delivery System

This study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve.


Locations(3)

Emory Midtown

Atlanta, Georgia, United States

Montefiore Medical Center

The Bronx, New York, United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07517588


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