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