NCT06597188

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

Comparison of Transcatheter Aortic Valve Replacement With Surgical Aortic Valve Replacecment: A Prospective, Multicenter, International, Randomized Controlled, Non-inferiority Study for Bicuspid Aortic Valve Stenosis (PROMIS-BAV)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Transcatheter aortic valve replacement (TAVR) has emerged as the first-line treatment for symptomatic severe AS currently, while TAVR for bicuspid aortic valve (BAV) stenosis has not been well demonstrated in randomized controlled trials, thus more randomized controlled studies of TAVR vs. SAVR are still needed to provide strong evidence that TAVR treatment for patients with BAV stenosis has good safety and effectiveness. This study is a prospective, international multicenter, randomized controlled, non-inferiority clinical study, in which the study device (VitaFlow Liberty®) for TAVR is to be demonstrated as non-inferior to the control device (a commercially available surgical bioprosthetic valve) for SAVR in terms of the incidence of composite endpoint events (all-cause mortality, all strokes and re-hospitalizations) at 12 months postoperatively. In this study, 452 eligible subjects will be randomly assigned to the study group (n=226) or the control group (n=226) in a 1:1 ratio. The subjects in study group will be treated with the TAVR surgery using the study device (VitaFlow Liberty®) , while the subjects in control group will be treated with the SAVR surgery using the control device (a commercially available surgical bioprosthetic valve), and clinical follow-ups will be performed at discharge (or 7 days after surgery), 30 days, 6 months, 12 months, and 2, 3, 4, 5 years after surgery, respectively.

Conditions

• Aortic Stenosis
• Bicuspid Aortic Valve (BAV)

Interventions

Type	Name	Description
DEVICE	VitaFlow Liberty	All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty
DEVICE	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.

Timeline

• Start date: 2025-09-08
• Primary completion: 2028-09-30
• Completion: 2032-09-30
• First posted: 2024-09-19
• Last updated: 2025-09-16

Locations

1 site across 1 country: China