Clinical Trial

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

Study acronym: EXPLORE-MRace
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07517588
Lead Sponsor Polares Medical SA
Conditions Mitral Regurgitation
Enrollment 15 participants
Start Date 2026-06-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08