AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System 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, and long-term clinical outcomes over a follow-up of 2 years.
The Cardiovalve offers a mitral replacement valve delivered through a transfemoral access and
 transseptal approach, and is intended to reduce mortality and adverse event rates in selected
 patients for whom surgical options are not feasible.

 Innovation: A truly trans femoral, trans venous delivery of the prosthetic mitral valve which
 minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust
 radial strength with decoupling of the atrial flange and ventricular portion which contains
 24 grasping legs designed for atraumatic anchoring of the device to the native mitral
 annulus. Valve leaflets are made of bovine pericardium. The Cardiovalve implant has a very
 low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract
 obstruction and/or interference with the LV. The Cardiovalve delivery system (DS) is designed
 for transfemoral delivery of the Implant with transseptal access to the left atrium. The
 catheter assembly is used to center the implant relative to the native mitral valve plane and
 align it with the left ventricual apex-to-base axis. After valve implantation, the delivery
 system is withdrawn.
General Inclusion Criteria

 1. Age ≥ 18 years

 2. NYHA functional II, III or ambulatory IV

 3. Severe mitral regurgitation (MR grade 3-4+)

 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)

 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