NCT07517588

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Polares Medical SA · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	MR-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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-31
• Completion: 2031-12-31
• First posted: 2026-04-08
• Last updated: 2026-04-08

Regulatory

• FDA-regulated device study