EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States) (NCT07517588) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
15 participantsStarted 2026-06-01
Plain-language 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
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
Exclusion criteria
✕. Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
✕. Left ventricular ejection fraction (LVEF) \< 30%