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

Recruiting now · Not applicable

Conditions studied: Severe Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07414342

Run by

Beijing Balance Medical Technology Co., Ltd

People needed

800

Starts

2026-02-01

Expected to finish

2037-09-01

Last updated by the study team

2026-02-17

Who can join

Age: 60 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
• Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
• 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 multivalvular disease (severe stenosis and/or regurgitation);
• 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 untreated coronary artery disease requiring revascularization;
• Patients with obstructive hypertrophic cardiomyopathy;
• Patients with severe left ventricular dysfunction (LVEF <20%);
• Patients with severe right ventricular dysfunction;
• Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
• Patients unable to tolerate anticoagulant or antiplatelet therapy;
• 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;
• Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
• Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.

Where it is running

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

Full record on ClinicalTrials.gov

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