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

This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.

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