Polares Medical SA
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
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…
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.
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