An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary 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 100 patients at four (4) centers in the Republic of Georgia.
18 years of age or older
Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
Patient must present with an STS Score less than 10%
High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
Severe tricuspid regurgitation
Severe aortic stenosis or insufficiency
Severe mitral annulus calcification
Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
Single group
Transcatheter mitral valve repair (MRace Implant and Delivery System)
DeviceThe MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Primary safety outcome
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Primary Performance Endpoint
Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the MRace Implant and Delivery System as evaluated by TTE
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