Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Recruiting now · Not applicable
Conditions studied: Aortic Valve Disease
In brief
Prospective, multicenter, randomized trial.
Key facts
- Study ID
- NCT04864145
- Run by
- Nanjing First Hospital, Nanjing Medical University
- People needed
- 210
- Starts
- 2021-05-21
- Expected to finish
- 2031-05-30
- Last updated by the study team
- 2026-04-08
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) > 65mm or left ventricular end-systolic dimension (LVESD) > 50mm;
- Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;
- The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
- STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
- Severe aorta calcification or active ascending aorta atherosclerotic plaque
- History of mediastinum radiotherapy
- Past mediastinitis
- Presence of unobstructed coronary bypass implants
- Previous more than two cardiothoracic surgeries
- Liver cirrhosis
- Other surgical risk factors
You may not qualify if…
- Age < 60 years old;
- Ascending aorta diameter >45mm;
- Coronary multi-vessel disease (SYNTAX score >32);
- Life expectancy <1 year;
- Left ventricular ejection fraction <30%;
- Acute myocardial infarction within 30 days;
- Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
- Other situations judged by the researcher as unsuitable for participating in the study.
Where it is running
- Nanjing First Hospital — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.