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

NARecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 21, 2021

Primary Completion Date

December 30, 2025

Study Completion Date

May 30, 2031

Conditions
Aortic Valve Disease
Interventions
DEVICE

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.

DRUG

Medical therapy

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

Trial Locations (1)

210006

RECRUITING

Nanjing First Hospital, Nanjing

All Listed Sponsors
lead

Nanjing First Hospital, Nanjing Medical University

OTHER