Clinical Trial in China for Aortic Valve Stenosis

Inclusion Criteria:

1. Age ≥ 65;

2. Patients with symptomatic aortic valve regurgitation diseases, and New York HeartAssociation (NYHA) ≥ II;

3. Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have beenevaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factorsprevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness,chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: ageof inoperable patients can be expanded to ≥ 50);

4. Aortic valve anatomy is suitable for TAVR evaluated by the investigators;

5. Patients who can sign informed consent form, and are willing to accept relevantexaminations and clinical follow-ups.

Exclusion Criteria:

1. Active endocarditis;

2. Acute myocardial infarction or coronary revascularization occurred within 1 monthbefore procedure;

3. Cerebrovascular accident (CVA) occurred within 30 days before procedure;

4. The echocardiogram indicates the presence of mass, thrombus or vegetation in leftventricle and left atrium;

5. Hypertrophic obstructive cardiomyopathy;

6. Other valve diseases that need interventions;

7. Previous aortic valve implantation (mechanical or biological);

8. Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;

9. Known allergy or contraindication to all anticoagulation, or anticoagulation can notbe used during the TAVR;

10. In presence one of the following (from selection to the day of procedure index): aother diseases that may shorten life expectancy to less than 12 months (recurrent ormetastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroinand so on); c planned additional operations that may result in incompliance or dataconfusion;

11. Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;

12. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;

13. Hepatic encephalopathy or acute active hepatitis;

14. Receiving hemodialysis;

15. Bleeding tendency or history of coagulopathy or refuse to receive transfusion;

16. Active gastrointestinal (GI) ulcer or bleeding;

17. Severe dementia;

18. Patients who need emergency surgery for any reason;

19. Patients are participating in other drugs or medical devices clinical trial;

20. Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for humanvillous gonadotropin prior to enrollment in the study);

21. Other inappropriate occasions according to the investigators.