Status:
RECRUITING
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief Summary
Prospective, multicenter, randomized trial.
Detailed Description
Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro He...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2031
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04864145
Start Date
May 21 2021
End Date
May 30 2031
Last Update
June 26 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006