AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

Criteria the registry did not label

• General Inclusion Criteria
• Age ≥ 18 years
• NYHA functional II, III or ambulatory IV
• Severe mitral regurgitation (MR grade 3-4+)
• Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
• 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.
• 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.
  • Anatomical Inclusion Criteria
• Suitable for femoral access procedure and trans septal catheterization
• 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
• 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