Study of the GeminiOne Transcatheter Edge-to-Edge Repair System for Treating Severe Symptomatic Mitral Regurgitation in Adults

What this Trial Is About

Researchers are evaluating the GeminiOne Transcatheter Edge-to-Edge Repair TEER System for adults with severe, symptomatic mitral regurgitation MR. This multi-center, non-randomized clinical trial aims to confirm the safety and effectiveness of the device in patients who are at high risk for surgical intervention or have not responded to other therapies. The study is sponsored by Sierra Valve LLC and involves participants from centers in the United States, Canada, and Europe. Participants will receive the investigational GeminiOne TEER System, which includes a clip implant made from specialized alloys and a delivery system designed for left atrial placement through transfemoral trans-septal access. Up to 15 subjects will be treated initially, and the study will last about 72 months with a 12-month enrollment period. After implantation, participants will be followed for 60 months to monitor outcomes. During the study, participants will undergo assessments including echocardiography, functional status evaluation, and quality of life questionnaires at 30 days, 12 months, and annually thereafter. Researchers will track major adverse events, mortality, stroke, rehospitalizations, and changes in heart function and symptoms. Safety and procedural success will be monitored closely during the first 30 days post-implant, with continued evaluation throughout the follow-up period.

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.