EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
Sponsor: Polares Medical SA • ClinicalTrials.gov ID: NCT07796659
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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.
Interventions
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Transcatheter mitral valve repair (MRace Implant and Delivery System)
(Device)
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Eligibility criteria
Conditions
Locations
- Israeli-Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia
- LLC "Emergency Cardilogy Center by Acad. G. Chapidze" — Tbilisi, Georgia
- Ltd Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia
- Ltd Tbilisi Heart Centre — Tbilisi, Georgia
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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