Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Cardiovalve Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Freedom from major device or procedure related serious adverse events
- Status
- Enrolling By Invitation
- Last Updated
- 3 months ago
Overview
Brief Summary
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Detailed Description
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible. The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •NYHA functional II, III or ambulatory IV
- •Severe mitral regurgitation (MR grade 3-4+)
- •High 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)
- •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.
- •Suitable for femoral access procedure and transseptal catheterization
- •Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
Exclusion Criteria
- •Prior stroke or TIA within 3 months
- •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
- •Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
Outcomes
Primary Outcomes
Freedom from major device or procedure related serious adverse events
Time Frame: 30 days
Freedom from major device or procedure related serious adverse events: F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Secondary Outcomes
- Technical success(Intraoperative)