This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
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;
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 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;