Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Exclusion Criteria

• •1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
• •2. Age less than 60 years
• •3. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
• •1. aspirin or heparin (HIT/HITTS) and bivalirudin
• •2. ticlopidine and clopidogrel
• •3. Nitinol (titanium or nickel)
• •4. contrast media
• •4. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• •5. Ongoing sepsis, including active endocarditis.
• •6. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
• •7. Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery.
• •8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
• •9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• •10. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• •11. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• •12. Subject refuses a blood transfusion.
• •13. 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).
• •14. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
• •15. 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.
• •16. Currently participating in an investigational drug or another device study (excluding registries).
• •17. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria).
• •18. Need for emergency surgery for any reason.
• •19. Subject is pregnant or breast feeding.
• •20. Subject is legally incompetent, or otherwise vulnerable
• •21. Pre-existing prosthetic heart valve in any position.
• •22. Severe mitral regurgitation amenable to surgical replacement or repair.
• •23. Severe tricuspid regurgitation amenable to surgical replacement or repair.
• •24. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
• •25. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
• •26. Prohibitive left ventricular outflow tract calcification.
• •27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis
• •28. Aortic annulus diameter of \<18 or \>30 mm.
• •29. Significant ascending aortopathy requiring surgical repair
• •30. Ascending aorta diameter \> 4.5 cm
• •For transfemoral or transaxillary (subclavian) access:
• •31. Access vessel mean diameter \<5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter \<5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<6.0 mm for the Evolut 34R or Evolut PRO TAV.