NCT04864145 Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
| NCT ID | NCT04864145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Aortic Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2021-05-21 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2021-05-21 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, multicenter, randomized trial.
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm; 3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05; 4. 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: 1. Severe aorta calcification or active ascending aorta atherosclerotic plaque 2. History of mediastinum radiotherapy 3. Past mediastinitis 4. Presence of unobstructed coronary bypass implants 5. Previous more than two cardiothoracic surgeries 6. Liver cirrhosis 7. Other surgical risk factors Exclusion Criteria: 1. Age \< 60 years old; 2. Ascending aorta diameter \>45mm; 3. Coronary multi-vessel disease (SYNTAX score \>32); 4. Life expectancy \<1 year; 5. Left ventricular ejection fraction \<30%; 6. Acute myocardial infarction within 30 days; 7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents); 8. Other situations judged by the researcher as unsuitable for participating in the study.
Contact & Investigator
Shao-Liang Chen, MD, PhD
STUDY CHAIR
Nanjing First Hospital, Nanjing Medical University
Frequently Asked Questions
Who can join the NCT04864145 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04864145 currently recruiting?
Yes, NCT04864145 is actively recruiting participants. Contact the research team at jameszll@163.com for enrollment information.
Where is the NCT04864145 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT04864145 clinical trial?
NCT04864145 is sponsored by Nanjing First Hospital, Nanjing Medical University. The principal investigator is Shao-Liang Chen, MD, PhD at Nanjing First Hospital, Nanjing Medical University. The trial plans to enroll 210 participants.