Cardiovalve Transfemoral Mitral Valve System (AHEAD)

This is an interventional treatment trial for Mitral Regurgitation Read More

Inclusion Criteria:

• 85>Age ≥ 18 years
• Symptomatic (Stage D) severe MR confirmed by the echo core lab
• Cardiac Index > 2.0
• Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE)
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa
• Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure
• Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert).

Exclusion Criteria:

• MR etiology that is exclusively Primary (degenerative)
• Echocardiographic or angiographic evidence of severe mitral annular calcification
• Echocardiographic evidence of EROA < 0.3cm2
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology
• Hypotension (systolic pressure < 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic
• Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure
• LVEDD >75 mm
• Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction.
• Anatomy deemed not suitable for the Cardiovalve
• Elevated Creatine Kinase-MB (CK-MB)
• UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
• Life Expectancy < 1 year due to non-cardiac conditions
• NYHA functional class IVb
• Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2
• Any prior mitral valve surgery or transcatheter mitral valve procedure
• Stroke or transient ischemic event within 30 Days prior to index procedure
• Modified Rankin Scale > 4 disability
• Class I indication for biventricular pacing (in patient with CRT device not implanted)
• Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
• Need for cardiovascular surgery (other than MV disease)
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Active endocarditis
• Known severe symptomatic carotid stenosis (> 70 % via ultrasound)
• Active infections requiring current antibiotic therapy
• Active cancer with expected survival < one year
• Pregnant or planning pregnancy within next 12 months.
• Currently participating in an investigational drug or another device study
• Any condition making it unlikely the patient will be able to complete all procedures
• Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
• Subjects in whom transesophageal echocardiography is contraindicated
• Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, heparin, anticoagulation therapy) or hypersensitivity to nickel or titanium.