EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant

Recruiting N/A Interventional Study
Mitral Valve Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
10 (estimated)
Sponsor
Polares Medical SA · Industry
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About This Trial
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 10 patients at one (1) …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure 3. Patient must present with an STS Score less than 10% 4. High surgical risk for convent…
Contacts

Stephen Kao

+1 650 776 8433

skao@polaresmedical.com

CONTACT