The Medtronic TAVR 2.0 US Clinical Study

Exclusion Criteria

• •1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
• •2. 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
• •3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• •4. Untreated clinically significant coronary artery disease requiring revascularization
• •5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
• •6. End stage renal disease requiring chronic dialysis or creatinine clearance \<20 cc/min.
• •7. Ongoing sepsis, including active endocarditis
• •8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
• •9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
• •10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• •11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• •12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
• •13. Subject refuses a blood transfusion
• •14. 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)
• •15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
• •16. 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
• •17. Currently participating in an investigational drug or another device study (excluding registries)
• •18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
• •19. Need for emergency surgery for any reason
• •20. Liver failure (Child-Pugh class C)
• •21. Subject is pregnant or breast feeding
• •22. Pre existing prosthetic heart valve in any position
• •23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
• •24. Severe mitral regurgitation
• •25. Severe tricuspid regurgitation
• •26. Moderate or severe mitral stenosis
• •27. Hypertrophic obstructive cardiomyopathy
• •28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
• •29. Congenital bicuspid or unicuspid valve verified by echocardiography
• •30. Access vessel diameter \<5.5 mm or \<6.0 mm for patent left internal mammary artery (LIMA)