Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 100 years old?
Source: NCT07414342, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Balance Medical Technology Co., Ltd
- Trial code
- NCT07414342
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Patients unable to tolerate anticoagulant or antiplatelet therapy; Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint; Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month; Patients with multivalvular disease (severe stenosis and/or regurgitation); Patients with untreated coronary artery disease requiring revascularization; Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months; Patients with decompensated renal insufficiency; Patients with active infective endocarditis or other active infections; Patients with untreated conduction system disease requiring pacemaker implantation; Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention; 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; Patients with severe left ventricular dysfunction (LVEF <20%); Patients with a life expectancy of ≤1 year following prosthetic valve implantation; Patients with minimal or no calcification of the aortic annulus; Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation; Patients with obstructive hypertrophic cardiomyopathy; Patients with severe right ventricular dysfunction; Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography.