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TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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)

NCT06597188•Shanghai MicroPort CardioFlow Medtech Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject aged ≤ 75 years;
•2. With symptomatic severe bicuspid aortic stenosis, defined as: peak flow velocity ≥ 4.0m/s, or mean trans-aortic pressure gradient ≥ 40mmHg, or aortic orifice area (AVA) ≤ 1.0cm2 (or AVA index ≤ 0.6cm2/m2) confirmed by echocardiography；
•3. New York Heart Association (NYHA) cardiac function classification ≥ Class II;
•4. With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
•5. Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria

•1. Known allergy or resistance to study device and control device components such as nitinol or contrast media;
•2. Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
•3. Known presence of active infective endocarditis or other active infection;
•4. Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
•5. Ascending aorta width ≥50mm;
•6. Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
•7. The aortic root anatomy not suitable for transcatheter aortic valve implantation confirmed by preoperative imaging (including aortic root calcification that influence the sufficient dilatation of the rposthetic valve);
•8. Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
•9. Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery;
•10. Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation);
+13 more criteria

Locations (1)

WEST CHINA Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

September 8, 2025

Primary Completion Date

September 30, 2028

Completion Date

September 30, 2032

Last Updated

September 16, 2025

Enrollment

452

ESTIMATED participants

Conditions

Aortic StenosisBicuspid Aortic Valve (BAV)

Interventions

VitaFlow Liberty

DEVICE

Commercially available surgical bioprosthetic valve

DEVICE

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

NCT06689839

Aortic Stenosis Treated With TAVIAortic Diseases

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RECRUITINGNA

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

NCT05511792

Aortic Stenosis With Bicuspid Valve

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

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