Actively Recruiting
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-04-08
210
Participants Needed
1
Research Sites
523 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, randomized trial.
CONDITIONS
Official Title
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic severe aortic regurgitation; or no symptoms but left ventricular ejection fraction (LVEF) 55% or less; or left ventricular end-diastolic dimension (LVEDD) over 65mm; or left ventricular end-systolic dimension (LVESD) over 50mm
- Severe aortic valve regurgitation with mean pressure gradient less than 20mmHg and annular perimeter 85mm or less
- Ratio of left ventricular outflow tract perimeter to valve annulus perimeter between 0.95 and 1.05
- STS score 8 or higher, or moderate to severe frailty, or refusal of surgical valve replacement, or presence of difficult surgical risk factors such as severe aorta calcification, history of mediastinum radiotherapy, past mediastinitis, unobstructed coronary bypass implants, more than two prior cardiothoracic surgeries, liver cirrhosis, or other surgical risk factors
You will not qualify if you...
- Age under 60 years
- Ascending aorta diameter over 45mm
- Coronary multi-vessel disease with SYNTAX score over 32
- Life expectancy less than 1 year
- Left ventricular ejection fraction less than 30%
- Acute myocardial infarction within 30 days
- Allergies or contraindications to aspirin, clopidogrel, warfarin, or contrast agents
- Other conditions judged by the researcher as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
J
Jun-Jie Zhang, MD, PhD
CONTACT
J
Jing Kan, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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