452
Participants
Start Date
September 8, 2025
Primary Completion Date
September 30, 2028
Study Completion Date
September 30, 2032
VitaFlow Liberty
All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty
Commercially available surgical bioprosthetic valve
All subjects randomized to the SAVR group will receive surgical aortic valve replacement (SAVR) with the control device of a commercially available surgical bioprosthetic valve.
WEST CHINA Hospital of Sichuan University, Chengdu
West China Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Zhejiang University
OTHER
Qilu Hospital of Shandong University
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Provincial Hospital of fuzhou University
UNKNOWN
Yanan Hospital of Kunming City
UNKNOWN
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
INDUSTRY