To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

Exclusion Criteria

• •1. Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm
• •2. Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition).
• •3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
• •4. Hematological abnormality, defined as: Leukopenia (WBC \<3×109/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L), history of bleeding diathesis or coagulopathy.
• •5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%.
• •6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
• •7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
• •8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
• •9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• •10. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.