TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis

Exclusion Criteria

• •1. Known allergy or resistance to study device and control device components such as nitinol or contrast media;
• •2. Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
• •3. Known presence of active infective endocarditis or other active infection;
• •4. Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
• •5. Ascending aorta width ≥50mm;
• •6. Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
• •7. The aortic root anatomy not suitable for transcatheter aortic valve implantation confirmed by preoperative imaging (including aortic root calcification that influence the sufficient dilatation of the rposthetic valve);
• •8. Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
• •9. Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery;
• •10. Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation);
• •11. Clinically diagnosed stroke or TIA within 3 months prior to surgery;
• •12. Gastrointestinal bleeding requiring hospitalization or transfusion therapy or other clinically significant bleeding or coagulation disorders within 3 months prior to surgery, which preclude the required antiplatelet therapy in the study;
• •13. Comorbid with severe native coronary artery lesions that require revascularization therapy;
• •14. Comorbid with severe mitral or tricuspid regurgitation;
• •15. Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;
• •16. Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF \<20%);
• •17. Comorbid with end-stage renal diseases requiring chronic dialysis;
• •18. Comorbid with blood dyscrasias defined as leukopenia (white blood cell count \< 3×109/L), thrombocytopenia (platelet count \< 50×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable states;
• •19. Subjects corresponding to the criteria of a vulnerable population (including patients who are unable to fully understand all aspects of the study, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment);
• •20. Female subjects known to be pregnant or lactating;
• •21. Life expectancy is less than 12 months as assessed by the investigator;
• •22. Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively;
• •23. Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study.