Clinical Trial in China

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.