A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 15 patients at 1 center in Australia
Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of optimized guideline-directed medical therapy (GDMT) per the Local Heart Team.
Functional MR graded 3+ or higher 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.
Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
Left ventricular ejection fraction (LVEF) < 30%
Pulmonary artery systolic pressure (PASP) > 70mmHg or > 2/3 SBP (Systolic Blood Pressure)
Left Ventricle End Diastolic Volume (LV EDV) > 200mL for males; >130mL for females
Single group
Transcatheter mitral valve repair
DeviceThe MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Primary Safety Endpoint
The primary safety endpoint is all-cause mortality at 30 days post-index procedure.
Primary Performance Endpoint
Improvement from baseline to moderate or less mitral regurgitation (Grade 2+ or less) at 30 days as evaluated by 2D transthoracic echocardiography.
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