The Medtronic TAVR 2.0 US Clinical Study

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Inclusion criteria

• Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
• Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
• Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
• The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion criteria

• Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:

• aspirin or heparin (HIT/HITTS) and bivalirudin
• ticlopidine and clopidogrel
• nitinol (titanium or nickel)
• contrast media
• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Untreated clinically significant coronary artery disease requiring revascularization
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
• End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
• Ongoing sepsis, including active endocarditis
• Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Gastrointestinal (GI) bleeding that would preclude anticoagulation
• Subject refuses a blood transfusion
• Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
• Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid 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-up exams
• Currently participating in an investigational drug or another device study (excluding registries)
• Evidence of an acute myocardial infarction ≤30 days before the study procedure
• Need for emergency surgery for any reason
• Liver failure (Child-Pugh class C)
• Subject is pregnant or breast feeding
• Pre existing prosthetic heart valve in any position
• Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
• Severe mitral regurgitation
• Severe tricuspid regurgitation
• Moderate or severe mitral stenosis
• Hypertrophic obstructive cardiomyopathy
• Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
• Congenital bicuspid or unicuspid valve verified by echocardiography
• Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)