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;
Single group
RENATUS® TAVR
DeviceRENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
Procedural success rate
Device success rate;
All-cause mortality at 1, 3, 5, and 10 years
Transvalvular pressure gradient at 30 days and 1 year post-procedure;
Valve performance changes: valvular regurgitation, paravalvular leak, etc.;
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE): death, disabling stroke, myocardial infarction, arrhythmia, conduction block, pacemaker implantation, etc.
Incidence of valve-related complications: infective endocarditis, hemolysis, valve stenosis, prosthetic valve failure, and other manifestations of valve dysfunction
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