TReanscAtheter TreatMent of PurE Aortic Regurgitation with VitaFlow Liberty System

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
AORTIC VALVE DISEASESAortic RegurgitationTranscatheter Aortic Valve Replacement (TAVR)
Interventions
COMBINATION_PRODUCT

TAVR+GDMT

"The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system.~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."

COMBINATION_PRODUCT

SAVR+GDMT

The patient will undergo conventional surgical aortic valve replacement on the basis of guideline-directed medical therapy.

Trial Locations (4)

200025

Ruijin hospital, Shanghai JiaoTong University School of Medicine, Shanghai

200030

Shanghai Chest Hospital, Shanghai

200032

Zhongshan Hospital, Fudan University, Shanghai

200433

Changhai Hospital, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER