Transcatheter Aortic Valve Replacement System Pivotal Trial

Exclusion Criteria

• •1. Left ventricular ejection fraction (LVEF) \<20% determined by resting echocardiogram.
• •2. Subjects with an acute STEMI within 30 days preceding the index procedure.
• •3. Chronic kidney disease with creatinine clearance \< 20 ml/min.
• •4. Subjects with a platelet count of \<50,000 cells/mm³ or a WBC \< 1000 cells/mm³ within 7 days prior to index procedure.
• •5. Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors) that cannot be adequately pretreated, or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
• •6. Any subject with a balloon valvuloplasty (BAV) within 72 hours prior to the index procedure.
• •7. Subjects who are on a waiting list for any organ transplant.
• •8. Subjects with known other medical illness associated with a life expectancy of less than one year, or expectation that subject will not improve despite treatment of aortic stenosis.
• •9. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or polyurethanes.
• •10. Subjects with a history of a stroke or transient ischemic attack (TIA) within previous 60 days of index procedure.
• •11. Subjects with an active gastrointestinal (GI) bleed or bleeding precluding dual antiplatelet therapy.
• •12. Subjects presenting with hemodynamic instability or cardiogenic shock requiring inotropic support or mechanical support devices.
• •13. Subjects who have a planned treatment with any other investigational device or procedure through 1 year follow-up, or who are currently participating in an investigational drug or another device trial.
• •14. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TAVR procedure.
• •15. Untreated clinically significant coronary artery disease requiring revascularization.
• •16. Newly identified left atrial thrombus that has not been treated.
• •17. Active endocarditis or sepsis within 6 months prior to the study procedure.
• •18. Any condition resulting in inability to provide informed consent for the trial or difficulty in assessment of neurologic status.
• •19. Congenital bicuspid or unicuspid valve.
• •20. Prior aortic valve surgery or pre-existing prosthetic heart valve in any position (mitral and tricuspid rings are permissible).
• •21. A native valve annulus diameter \<22mm or \>29mm determined by the screening CT scan.
• •22. Echocardiographic evidence of new intra-cardiac mass, untreated thrombus, or vegetation that requires treatment.
• •23. \>3+: aortic regurgitation, mitral regurgitation or tricuspid regurgitation.
• •24. Severe mitral or tricuspid stenosis.
• •25. Thoracic aortic aneurysm (TAA) \>5.50 cm.
• •26. Inability to transfuse blood.
• •27. Subject has femoral arterial access that is not acceptable for the study as defined in the device Instructions for Use.
• •28. Coronary anatomy that precludes the perfusion of native coronary arteries post-implant.
• •29. Prohibitive left ventricular outflow tract (LVOT) calcification that would prevent proper deployment of a transcatheter valve.