Cardiovalve Transfemoral System - FIM Study

Prior treatment

• 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

Other illness

• 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
• 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)
• Severe tricuspid or aortic valve disease General Exclusion Criteria
• 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
• 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

Lab values

• Left Ventricular Ejection Fraction ( LVEF) \<30%
• Patients with renal insufficiency (creatinine \> 2.5 mg/dL)

Other

• Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
• 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
• Severe right ventricular dysfunction
• Subject who is currently participating in an investigational study, other than this study
• Pulmonary artery systolic pressure \>70 mmHg
• Subject is pregnant, breastfeeding or intend to become pregnant within one year

• 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