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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02948231
Study type Interventional
Source Mitralix
Contact
Status Completed
Phase N/A
Start date June 25, 2016
Completion date February 2022

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