A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

Exclusion Criteria

• •1. Previous surgical or/and transcatheter cardiac valve replacement at any site
• •2. Previous open-heart surgical valve repair at any site
• •3. Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
• •4. Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
• •5. Untreated clinically significant coronary artery diseases requiring revascularization
• •6. Acute myocardial infarct within the previous 30 days
• •7. Severe right heart dysfunction
• •8. Active infection requiring antibiotic therapy including infective endocarditis
• •9. Hypertrophic obstructive cardiomyopathy (HOCM)
• •10. Severe symptomatic carotid artery stenosis
• •11. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
• •12. Chronic kidney disease (eGFR\<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
• •13. Hematologic disorders: Leukopenia (WBC \< 3000 cell/mL), anemia (Hgb \< 9 g/dL), thrombocytopenia (Plt\< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
• •14. Severe chronic lung disease
• •15. Previous organ transplant or currently an organ transplant candidate Anatomical
• •16. LVEF \< 20%
• •17. Left ventricular end diastolic diameter (LVEDD) \>70mm
• •18. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• •19. Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
• •20. Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
• •21. Urgent, emergency or salvage surgeries
• •22. Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
• •23. Life expectancy ≤ 1 year due to non-cardiac reasons
• •24. Planned relevant concomitant procedure within 30 days post index procedure
• •25. Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
• •26. Pregnant, breastfeeding or intend to become pregnant within 1 year
• •27. Currently incarcerated or unable to give voluntary informed consent