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

Summary

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.

Eligibility

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.

Conditions2

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