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

Inclusion Criteria: Age ≥ 18 years Patients who are clinically indicated for aortic valve replacement Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent Exclusion Criteria: Previous surgical or/and transcatheter cardiac valve replacement at any site Previous open-heart surgical valve repair at any site Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention Untreated clinically significant coronary artery diseases requiring revascularization Acute myocardial infarct within the previous 30 days Severe right heart dysfunction Active infection requiring antibiotic therapy including infective endocarditis Hypertrophic obstructive cardiomyopathy (HOCM) Severe symptomatic carotid artery stenosis Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis 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 Severe chronic lung disease Previous organ transplant or currently an organ transplant candidate Anatomical LVEF < 20% Left ventricular end diastolic diameter (LVEDD) >70mm Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Native aortic valve geometry and size unfavorable for study bioprosthetic valve General Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance Urgent, emergency or salvage surgeries Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement Life expectancy ≤ 1 year due to non-cardiac reasons Planned relevant concomitant procedure within 30 days post index procedure Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial Pregnant, breastfeeding or intend to become pregnant within 1 year Currently incarcerated or unable to give voluntary informed consent