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Clinical Trials in China / NCT04864145
Recruiting Not applicable

Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation

NCT04864145 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing First Hospital, Nanjing Medical University
Phase
Not applicable
Started
2021-05-21
Last updated
2026-04-08

Condition(s) studied

Aortic Valve Disease

Investigational drug(s) / intervention(s)

Transcatheter Aortic Valve ImplantationMedical therapy

Transcatheter Aortic Valve Implantation: The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.

Medical therapy: Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.

Study summary

Prospective, multicenter, randomized trial.

Eligibility

Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanjing First Hospital Nanjing Jiangsu Recruiting

More Nanjing First Hospital, Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04864145 on ClinicalTrials.gov ↗ ← All trials in China