Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)
Polares Medical SA
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team. Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of \> 50% or increase of \> 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT. 2. Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardio…
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 MidtownAtlanta, Georgia
- Montefiore Medical CenterThe Bronx, New York
- The Lindner Research Center at The Christ HospitalCincinnati, Ohio