Clinical Trial

TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis

Study acronym: PROMIS-BAV
Enrolling by Invitation
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Summary
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-13; most recent amendment 2025-09-10.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-09-10
Trial Details
NCT Number NCT06597188
Lead Sponsor Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Collaborators: West China Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Zhejiang University, Qilu Hospital of Shandong University, People's Hospital of Xinjiang Uygur Autonomous Region, Provincial Hospital of fuzhou University, Yan'an Affiliated Hospital of Kunming Medical University
Conditions Aortic Stenosis, Bicuspid Aortic Valve (BAV)
Enrollment 452 participants
Start Date 2025-09-08
Primary Completion 2028-09-30 (estimated)
Study Completion 2032-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-16