Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR 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

 1. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability

 2. Acute myocardial infarction within the previous 30 days

 3. Any prior heart valve surgery or transcatheter mitral intervention

 4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid
 surgery within 30 days

 5. Rheumatic heart disease or endocarditis within the previous 3 months

 6. 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

 7. Existence of inferior vena cava filter or atrial septal device (contraindicating
 femoral access and transseptal catheterization)

 8. Untreated clinically signiﬁcant coronary artery disease requiring revascularization

 9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation

 10. Aortic or pulmonic valve disease requiring surgery

 11. CRT/ICD implant within 30 days Anatomical Exclusion Criteria (assessed by
 pre-procedural imaging)

 12. Left Ventricular Ejection Fraction (LVEF) <30%

 13. LV end diastolic diameter > 70mm

 14. Significant abnormalities of the mitral valve and sub-valvular apparatus.

 15. Severe mitral annular or leaflets calcification

 16. Left atrial or LV thrombus or vegetation

 17. Severe right ventricular dysfunction

 18. Severe tricuspid or aortic valve disease

 General Exclusion Criteria

 19. Subject who is currently participating in an investigational study, other than this
 study

 20. 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

 21. 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

 22. Bleeding diathesis or hypercoagulable state

 23. Active peptic ulcer or active gastrointestinal bleeding

 24. Pulmonary artery systolic pressure >70 mmHg

 25. Patients with renal insufficiency (creatinine > 2.5 mg/dL)

 26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery
 within the next 12 months

 27. Subject with hepatic insufficiency

 28. Subject has a co-morbid illness that may result in a life expectancy of less than one
 year

 29. Active infection that requires antibiotic therapy

 30. Subject is pregnant, breastfeeding or intend to become pregnant within one year