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.
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical MRace Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The MRace Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
RECRUITINGLLC "Emergency Cardilogy Center by Acad. G. Chapidze"
Tbilisi, Georgia
RECRUITINGLtd Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
RECRUITINGLtd Tbilisi Heart Centre
Tbilisi, Georgia
RECRUITINGPrimary safety outcome
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Time frame: 30-days follow-up
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
Time frame: 30-days follow-up
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