120
Participants
Start Date
February 1, 2025
Primary Completion Date
November 30, 2027
Study Completion Date
November 30, 2027
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."
SAVR+GDMT
The patient will undergo conventional surgical aortic valve replacement on the basis of guideline-directed medical therapy.
Ruijin hospital, Shanghai JiaoTong University School of Medicine, Shanghai
Shanghai Chest Hospital, Shanghai
Zhongshan Hospital, Fudan University, Shanghai
Changhai Hospital, Shanghai
Ruijin Hospital
OTHER