Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)
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
• 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.
• Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
• Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
• The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies
• 21 years of age or older
• Native mitral valve geometry and size is compatible with the Polares MRace system
• Anatomy is suitable for transfemoral transseptal access with the Polares MRace system
• Patient is willing to participate in study and provides signed IRB/EC-approved informed consent
⁃ Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
⁃ Patient is approved by an independent Patient Eligibility Committee