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

Inclusion criteria

• 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;
• 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;
• 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

• Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
• Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
• Patients with minimal or no calcification of the aortic annulus;
• Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
• Patients with multivalvular disease (severe stenosis and/or regurgitation);
• 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;
• Patients with untreated coronary artery disease requiring revascularization;
• Patients with obstructive hypertrophic cardiomyopathy;
• Patients with severe left ventricular dysfunction (LVEF <20%);
• Patients with severe right ventricular dysfunction;
• Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
• Patients unable to tolerate anticoagulant or antiplatelet therapy;
• Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;
• Patients with decompensated renal insufficiency;
• Patients with active infective endocarditis or other active infections;
• Patients with untreated conduction system disease requiring pacemaker implantation;
• Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
• Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.