Actively Recruiting
Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Led by Beijing Balance Medical Technology Co., Ltd · Updated on 2026-02-17
800
Participants Needed
4
Research Sites
604 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for TAVR as determined by their treating physician, including high, intermediate, or low surgical risk
- Symptomatic severe aortic stenosis confirmed by echocardiography with at least one of the following: mean transvalvular pressure gradient 240 mmHg, peak aortic jet velocity 24.0 m/s, aortic valve area <1.0 cm, or indexed effective orifice area <0.6 cm/m
- Patients who understand the study purpose, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and follow-up
You will not qualify if you...
- Life expectancy 1 year after valve implantation
- Acute myocardial infarction or cardiac surgery within the past month
- Minimal or no calcification of the aortic annulus
- Unsuitable aortic root anatomy or pathology for valve implantation
- Severe multivalvular disease (stenosis and/or regurgitation)
- Hematologic cachexia including leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
- Untreated coronary artery disease requiring revascularization
- Obstructive hypertrophic cardiomyopathy
- Severe left ventricular dysfunction (LVEF <20%)
- Severe right ventricular dysfunction
- Intracardiac masses, fresh thrombi, or vegetations on echocardiography
- Cannot tolerate anticoagulant or antiplatelet therapy
- Stroke (ischemic or hemorrhagic) within past 3 months
- Decompensated renal insufficiency
- Active infective endocarditis or other active infections
- Untreated conduction system disease requiring pacemaker
- Participation in another clinical trial without reaching primary endpoint
- Any other condition making the patient unsuitable for transcatheter valve intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Actively Recruiting
2
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Actively Recruiting
3
Fu Wai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
4
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
L
Lai Yongqiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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