A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Exclusion Criteria

• •1. The imaging data shows that it is anatomically unsuitable for transcatheter aortic valve implantation;
• •2. Acute myocardial infarction (defined as Q-wave myocardial infarction, or non-Q-wave myocardial infarction with CK-MB≥ twice normal and/or elevated Tn (WHO definition)) occurring within 1 month before valve implantation);
• •3. Received any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation;
• •4. Implanted prosthetic heart valves at any location, or combined with other valves with severe stenosis or severe regurgitation;
• •5. Hemorrhagic constitution or coagulation dysfunction (platelet PLT\<50×10\^9/L);
• •6. Haemodynamic instability requiring continuous mechanical cardiac assistance;
• •7. Severe left ventricular dysfunction, left ventricular ejection fraction LVEF \<20%;
• •8. Echocardiography shows intracardiac thrombosis or vegetation, etc.;
• •9. Renal insufficiency decompensation (endogenous creatinine clearance rate\<20ml/min);
• •10. Active peptic ulcer or upper gastrointestinal bleeding within 3 months;
• •11. Cerebrovascular events (CVAs) within 3 months before valve implantation, excluding transient ischemic attack;
• •12. Allergy or contraindication to antiplatelet drugs, anticoagulant drugs, or contrast agents, resulting in the inability to perform preoperative or appropriate intraoperative medication, allergies, or contraindications to polymer materials;
• •13. Patients with active infective endocarditis or other active infections;
• •14. Concurrent participation in other drug or device studies.
• •15. In the opinion of the investigator, it is not suitable for enrollment.