Clinical Trial in China for Aortic Valve Stenosis

Inclusion Criteria: 1. Age ≥ 65; 2. Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II; 3. Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team \[defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of 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 relevant examinations and clinical follow-ups. Exclusion Criteria: 1. Active endocarditis; 2. Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; 3. Cerebrovascular accident (CVA) occurred within 30 days before procedure; 4. The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle 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 not be used during the TAVR; 10. In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; 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 human villous gonadotropin prior to enrollment in the study); 21. Other inappropriate occasions according to the investigators.