Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients with Severe Symptomatic Mitral Regurgitation - The Half Moon TMVr Pilot Study
Brief description of study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.Mitral valve regurgitation (MR) occurs when the two leaflets of your mitral valve do not close correctly and blood leaks backward with each heartbeat. This study will evaluate the feasibility of placing the TMVr system, safely and effectively, in humans who have MR.
Clinical Study Identifier: s20-01707
ClinicalTrials.gov Identifier: NCT04343313
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