Transcatheter Aortic Valve Replacement System Pivotal Trial

Inclusion criteria:

1. The subject has severe senile degenerative aortic valve stenosis determined byechocardiogram and Doppler, or simultaneous pressure recordings at cardiaccatheterization defined as: mean aortic gradient ≥40 mmHg, or an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.

2. The subject has moderate to severe symptoms from aortic valve stenosis (NYHAFunctional Class ≥II).

3. Subject has a documented aortic annulus size of ≥22 mm and <29 mm based on thecenter's assessment of pre-procedure diagnostic imaging (and confirmed by the PatientReview Committee [PRC]) and is deemed treatable with an available size of both testand control device.

4. There is agreement by the heart team (which must include a site cardiacinterventionalist and two cardiac surgeons which can be either two cardiac surgeonstaff members at the hospital where the procedure is to be performed or one surgeonfrom the hospital where the procedure is to be performed and a surgeon from thereferring institution or practice) that subject is at high operative risk or greaterof serious morbidity or mortality with surgical valve replacement (see note below fordefinitions of extreme and high risk, the required level of surgical assessment, andPRC confirmation) and that TAVR is appropriate. Subjects will be designated eitherextreme risk (defined as a mortality or irreversible morbidity 50% or great at 30days) or high risk (i.e., Society of Thoracic Surgeons operative risk score >8% or ata > 15% risk of surgical mortality at 30 days but not extreme risk). This conclusionshall be based on consensus of one cardiac interventionalist and two cardiac surgeonsthat have reviewed the case after careful consideration of the Subject's STS riskscore and co-morbidities.

5. Subject understands the study requirements and the treatment procedures, and provideswritten informed consent.

6. Subject agrees and is capable of returning to the study hospital for all requiredscheduled follow up visits.

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 7days 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 tobe anti-coagulated for the study procedure. Note: Subjects who require chronicanticoagulation must be able to be treated additionally with either aspirin orclopidogrel.

6. Any subject with a balloon valvuloplasty (BAV) within 72 hours prior to the indexprocedure.

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 lessthan one year, or expectation that subject will not improve despite treatment ofaortic stenosis.

9. Subject has known hypersensitivity to contrast agents that cannot be adequatelypre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, orpolyurethanes.

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 dualantiplatelet therapy.

12. Subjects presenting with hemodynamic instability or cardiogenic shock requiringinotropic support or mechanical support devices.

13. Subjects who have a planned treatment with any other investigational device orprocedure through 1 year follow-up, or who are currently participating in aninvestigational drug or another device trial.

14. Any planned surgical, percutaneous coronary or peripheral procedure to be performedwithin 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 ordifficulty 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, orvegetation 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 inthe device Instructions for Use.

28. Coronary anatomy that precludes the perfusion of native coronary arteriespost-implant.

29. Prohibitive left ventricular outflow tract (LVOT) calcification that would preventproper deployment of a transcatheter valve.