Mitral Valve Regurgitation Clinical Trial
Official title:
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint). The main objectives of the study are : - Evaluate the Acute safety of the implanted Mistral device post procedure and at 30 day follow up period. - Evaluate the long term Safety of the device (3 and 6 months follow up). - Demonstrate effectiveness of the Mistral device in improving MR. Primary endpoints: • Safety: Acute safety. Rate of device related SAE including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event. At discharge and 30 days. Secondary endpoints: - • Safety: Safety at 3 and 6 months. Rate of SAEs and device related SAEs at 3, 6 and 12months. - Effectiveness: MR reduction post-procedure, at discharge and 30 days, 3 and 6 and 12 months. Improved NYHA class and 6MWT distance at 30 days, 3 and 6 and 12 months. ;
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