NCT07414342 Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
| NCT ID | NCT07414342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Balance Medical Technology Co., Ltd |
| Condition | Severe Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2026-02 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2026-02 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07414342 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 100 Years, studying Severe Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414342 currently recruiting?
Yes, NCT07414342 is actively recruiting participants. Contact the research team at yongqianglai@outlook.com for enrollment information.
Where is the NCT07414342 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT07414342 clinical trial?
NCT07414342 is sponsored by Beijing Balance Medical Technology Co., Ltd. The trial plans to enroll 800 participants.