RENATUS transcatheter aortic valve for severe aortic stenosis

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

This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 60 Years to 100 Years
• Sex: All
• Sponsor: Beijing Balance Medical Technology Co., Ltd (Industry-sponsored)
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT07414342 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, observational post-market follow-up that will monitor the safety and effectiveness of the RENATUS transcatheter aortic valve system in patients with symptomatic severe aortic stenosis. Participants judged eligible for transcatheter aortic valve replacement by their treating physician will receive the RENATUS device and undergo scheduled clinical and echocardiographic follow-up. The study will collect procedural outcomes, valve performance measures such as mean gradient and valve area, and adverse event data over time. Findings will inform longer-term device safety and performance in a real-world population.

Who should consider this trial

Good fit: Adults with symptomatic severe aortic stenosis who are judged by their physician to be appropriate candidates for TAVR and who can provide informed consent and attend follow-up visits.

Not a fit: Patients with a life expectancy of one year or less after valve implantation, those with a recent myocardial infarction or recent cardiac surgery, or those with insufficient aortic valve calcification to anchor the device are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the RENATUS valve could provide a safe and effective TAVR option that reduces symptoms and improves valve function for patients with severe aortic stenosis.

How similar studies have performed: Transcatheter aortic valve replacement using other commercially available valves has been widely studied and shown benefit across surgical risk groups, so this post-market study builds on established outcomes for similar devices.

Eligibility criteria

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.

Where this trial is running

Beijing and 3 other locations

• Beijing Anzhen Hospital, Capital Medical University — Beijing, China (Recruiting)
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, China (Recruiting)
• Fu Wai Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lai Yongqiang

Conditions Severe Aortic Stenosis