MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Mitralix
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is willing and able to comply with all required follow-up evaluations
- •Genders eligible for the study: Both genders
- •Subject has functional MR of grade 3+ or more
- •Subject has left ventricular ejection fraction (LVEF) \>20 % and \< 40%.
- •No contraindications to trans-septal puncture
- •Subject is of functional class 3 or more (NYHA)
- •The subject is high risk to undergo MV surgery.
- •Subject is excluded from other standard of care procedures as determined by center heart team.
- •Patients with femoral veins enabling catheterization with 12Fr catheters
- •Life expectancy ≥ 1 year
Exclusion Criteria
- •Mitral Stenosis ≥ moderate
- •Aortic Stenosis/Insufficiency \> moderate
- •Subvalvular calcification or calcification of the chordae.
- •Subject has a prosthesis valve in the mitral position
- •Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration
- •Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
- •Subject has a history of a myocardial infarction (MI) in the past 3 months
- •Subject refuses blood transfusion or surgical valve replacement.
- •Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 7 days of the index procedure
- •Subject has a history of, or has active endocarditis
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Safety: Rate of device related SAE(at 12 months post procedure)
- Effectiveness: MR Grade reduction.(at 12 months post procedure)
- Effectiveness: NYHA class (categorization of heart failure extent).(Post procedure (1 hour after implant device has been implanted))
- Effectiveness: NYHA class (categorization of heart failure extent)(at 12 months post procedure)
- Effectiveness: 6MWT distance.(at 12 months post procedure)