Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Inclusion Criteria:

• Subject must have STS mortality risk score ≥4% and ≤10%;
• Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);

• Subject has severe aortic valve stenosis presenting with

  1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
  2. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 55%] or velocity ratio < 0.25;
• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:

• Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
• Any condition considered a contraindication for placement of a bioprosthetic valve (i.e. subject requires a mechanical valve);
• A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
• Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
• Ongoing sepsis, including active endocarditis;
• Any condition considered a contraindication to extracorporeal assistance;
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization;
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization;
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
• Recent (within 6 months of randomization)cerebrovascular accident (CVA) or transient ischemic attack (TIA);
• Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
• Subject refuses a blood transfusion;
• Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
• Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
• Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
• Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams;
• Currently participating in an investigational drug or another device trial (excluding registries);
• Evidence of an acute myocardial infarction ≤30 days before the index procedure;
• Need for emergency surgery for any reason;
• True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
• Extensive mediastinal radiation;
• Liver failure (Child-C);
• Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
• Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
• End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
• Pulmonary Hypertension (systolic pressure> 80mmHg);
• Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;

• Frailty assessments identify:

  1. Subject is < 80 years of age and three or more of the following apply

  2. Subject is ≥ 80 years of age and two or more of the following apply

     • Wheelchair bound
     • Resides in an institutional care facility (e.g. nursing home, skilled care center)
     • Body Mass Index < 20 kg/m2
     • Grip Strength < 16 kg
     • Katz Index Score ≤ 4
     • Albumin < 3.5 g/dL
• Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention;

Note: Additional anatomical and vascular exclusion criteria may apply.