Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

Inclusion Criteria: 1. Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score; 2. Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following: * Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa), * Peak aortic jet velocity ≥4.0 m/s, * Aortic valve area \<1.0 cm², or Indexed effective orifice area \<0.6 cm²/m²; 3. Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up. Exclusion Criteria: 1. Patients with a life expectancy of ≤1 year following prosthetic valve implantation; 2. Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month; 3. Patients with minimal or no calcification of the aortic annulus; 4. Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation; 5. Patients with multivalvular disease (severe stenosis and/or regurgitation); 6. Patients with hematologic cachexia, including leukopenia (WBC \<3×10⁹/L), acute anemia (Hb \<90 g/L), thrombocytopenia (PLT \<50×10⁹/L), bleeding diathesis, or coagulopathy; 7. Patients with untreated coronary artery disease requiring revascularization; 8. Patients with obstructive hypertrophic cardiomyopathy; 9. Patients with severe left ventricular dysfunction (LVEF \<20%); 10. Patients with severe right ventricular dysfunction; 11. Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography; 12. Patients unable to tolerate anticoagulant or antiplatelet therapy; 13. Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months; 14. Patients with decompensated renal insufficiency; 15. Patients with active infective endocarditis or other active infections; 16. Patients with untreated conduction system disease requiring pacemaker implantation; 17. Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint; 18. Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.