ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

Exclusion Criteria

• •1. Unicuspid or bicuspid aortic valve
• •2. Extreme eccentricity of calcification
• •3. Severe mitral regurgitation ( \>2+)
• •4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
• •5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant
• •6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
• •7. Presence of endovascular stent graft for treatment of TAA or AAA
• •8. Trans-esophageal echocardiogram (TEE) is contraindicated
• •9. Left Ventricle Ejection Fraction (LVEF) \< 30% by echocardiography (ECHO)
• •10. ECHO evidence of intracardiac mass, thrombus, or vegetation
• •11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure
• •12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
• •13. Previous Transient Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure
• •14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
• •15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
• •16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
• •17. Systolic pressure \<80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)
• •18. Primary hypertrophic obstructive cardiomyopathy (HOCM)
• •19. Active infection, endocarditis or pyrexia
• •20. Hepatic failure
• •21. Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis
• •22. Refusal of surgery
• •23. Severe Chronic Obstruction Pulmonary Disease (COPD) requiring home oxygen
• •24. Neurological disease severely affecting ambulation or daily functioning, or dementia
• •25. Life expectancy \< 12 months due to non-cardiac co-morbid conditions
• •26. Known hypersensitivity/contraindication to study medication, contrast media, or nitinol
• •27. Currently participating in an investigational drug or another device study