Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Clinical worsening — 12 months
A composite of all cause death, disabling stroke, or heart failure rehospitalization
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | Recruiting |
More Nanjing First Hospital, Nanjing Medical University trials in China
Other trials for the same condition
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