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

Overview

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.

Interventions

• Device RENATUS® TAVR
  RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR

Primary outcome measures

• Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths) [Time frame: 1 year post-procedure]

Secondary outcome measures (3)

• Procedural success rate [Time frame: Perioperative]
• Device success rate; [Time frame: Perioperative]
• All-cause mortality at 1, 3, 5, and 10 years [Time frame: 1, 3, 5, and 10 years]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 4 centers

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

Identifiers

NCT: NCT07414342 · KS2026002 · Z251100004625015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗