Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
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.
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.
General Inclusion Criteria:
2. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology 4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
5. 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.
6. Able to undergo Transesophageal Echocardiography (TEE). 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
Anatomical Inclusion Criteria 9. Suitable for femoral access procedure and trans septal catheterization 10. 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
Aortic or pulmonic valve disease requiring surgery
CRT/ICD implant within 30 days Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
Left Ventricular Ejection Fraction (LVEF) <30%
LV end diastolic diameter > 70mm
Significant abnormalities of the mitral valve and sub-valvular apparatus.
Severe mitral annular or leaflets calcification
Left atrial or LV thrombus or vegetation
Severe right ventricular dysfunction
Severe tricuspid or aortic valve disease
General Exclusion Criteria
Subject who is currently participating in an investigational study, other than this study
Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance
Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications
Bleeding diathesis or hypercoagulable state
Active peptic ulcer or active gastrointestinal bleeding
Pulmonary artery systolic pressure >70 mmHg
Patients with renal insufficiency (creatinine > 2.5 mg/dL)
Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months
Subject with hepatic insufficiency
Subject has a co-morbid illness that may result in a life expectancy of less than one year
Active infection that requires antibiotic therapy
Subject is pregnant, breastfeeding or intend to become pregnant within one year