Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Cardiovalve Ltd.
- Locations
- 2
- Primary Endpoint
- Freedom from major device- or procedure- related serious adverse events
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.
Detailed Description
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.
Investigators
Eligibility Criteria
Inclusion Criteria
- •NYHA functional II, III or ambulatory IV
- •Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology
- •Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
- •Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
- •Able to undergo Transesophageal Echocardiography (TEE).
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- •The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- •Anatomical Inclusion Criteria
- •Suitable for femoral access procedure and trans septal catheterization
- •Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)
Exclusion Criteria
- •Cardiovascular Exclusion Criteria
- •Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
- •Acute myocardial infarction within the previous 30 days
- •Any prior heart valve surgery or transcatheter mitral intervention
- •Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- •Rheumatic heart disease or endocarditis within the previous 3 months
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- •Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
Outcomes
Primary Outcomes
Freedom from major device- or procedure- related serious adverse events
Time Frame: 30 days
Evaluate the safety of the Cardiovalve with its associated procedure
Secondary Outcomes
- Technical success of delivery and deployment of the device(Intraoperative)
- Freedom from emergency surgery or reintervention(30 days)
- Freedom from rehospitalizations or reinterventions due to the underlying condition(30 days, 3 Months, 6 Months, 12 Months, and 24 Months)
- 6 minute walk test(30 days, 3-, 6-, 12 and 24-months)
- Improvement in quality of life from baseline(30 days, 3-, 6-, 12 and 24-months)
- NYHA class(30 days, 3-, 6-, 12 and 24-months)
- Reduction in MR grade(30 days, 3-, 6-, 12 and 24-months)