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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Mistral Implant is implanted in the Mitral valve
ZNA Middelheim
Antwerp, Belgium
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.
Time frame: Until hospital discharge - up to 5 days post procedure day
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.
Time frame: at 30 days post-procedure
Safety: Rate of device related SAE
Time frame: at 3 months post procedure
Safety: Rate of device related SAE
Time frame: at 6 months post procedure
Safety: Rate of device related SAE
Time frame: at 12 months post procedure
Effectiveness: MR Grade reduction.
Time frame: Post procedure (1 hour after implant device has been implanted)
Effectiveness: MR Grade reduction.
Time frame: Until hospital discharge - up to 5 days post procedure day
Effectiveness: MR Grade reduction.
Time frame: at 30 days post procedure
Effectiveness: MR Grade reduction.
Time frame: at 3 months post procedure
Effectiveness: MR Grade reduction.
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Time frame: at 6 months post procedure
Effectiveness: MR Grade reduction.
Time frame: at 12 months post procedure
Effectiveness: NYHA class (categorization of heart failure extent).
Time frame: Post procedure (1 hour after implant device has been implanted)
Effectiveness: NYHA class (categorization of heart failure extent)
Time frame: Until hospital discharge - up to 5 days post procedure day
Effectiveness: NYHA class (categorization of heart failure extent)
Time frame: at 30 days post procedure
Effectiveness: NYHA class (categorization of heart failure extent)
Time frame: at 3 months post procedure
Effectiveness: NYHA class (categorization of heart failure extent)
Time frame: at 6 months post procedure
Effectiveness: NYHA class (categorization of heart failure extent)
Time frame: at 12 months post procedure
Effectiveness: 6MWT distance.
Time frame: Post procedure (1 hour after implant device has been implanted)
Effectiveness: 6MWT distance.
Time frame: Until hospital discharge - up to 5 days post procedure day
Effectiveness: 6MWT distance.
Time frame: at 30 days post procedure
Effectiveness: 6MWT distance.
Time frame: at 3 months post procedure
Effectiveness: 6MWT distance.
Time frame: at 6 months post procedure
Effectiveness: 6MWT distance.
Time frame: at 12 months post procedure