Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Exclusion Criteria

• •1. defined as Q-wave myocardial infarction or non-Q-wave myocardial infarction with CK-MB level ≥ 2 times the upper limit of normal value and / or Tn increase.
• •2. Subjects with congenital unicuspid, without calcification.
• •3. Any therapeutic or traumatic cardiac surgery within 30 days (within 3 months in case of drug-eluting stents implantation)
• •4. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral annulus calcification (MAC), severe (\> 3 +) mitral insufficiency.
• •5. Hematological abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
• •6. Subjects with hemodynamic instability, requiring continuous mechanical heart assistance.
• •7. Subjects who need emergency surgery for any reason;
• •8. Hypertrophic cardiomyopathy with or without obstruction;
• •9. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
• •10. The echocardiogram indicates the presence of a thrombus or vegetation;
• •11. A history of active peptic ulcer or upper gastrointestinal bleeding within 3 months;
• •12. Are allergic to nickel titanium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
• •13. Cerebrovascular accident occurred within 6 months, including transient ischemic attack;
• •14. renal insufficiency(creatinine\> 3.0mg/dL) and/or end-stage renal disease requiring Renal dialysis;
• •15. Life expectancy\< 12 months;
• •16. Significant aortic diseases, including abdominal aortic or thoracic aortic aneurysm(defined as maximum lumen diameter \> 50mm, obvious distortion), atherosclerosis of the aortic arch(especially bulge with thickness \> 5mm or ulceration), narrowing of the abdominal or thoracic aorta(especially calcification and irregular surface), and severe curvature of the thoracic aorta;
• •17. The iliac-femoral artery cannot be inserted with a guide sheath of 22F or above, such as severely obstructed with calcification, severely tortuous or vessel diameter less than 6mm;
• •18. Screening participant who is participating in other drug or medical device clinical trials;
• •19. Active infective endocarditis or other active infections;
• •20. Anatomically, the approach or aortic root is not suitable for TAVR (such as a high risk of coronary artery occlusion).
• •21. Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.