TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis (PROMIS-BAV)

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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Stenosis; Bicuspid Aortic Valve (BAV)
• Intervention / Treatment: Device: VitaFlow Liberty; Device: Commercially available surgical bioprosthetic valve

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.

• Study Type: Interventional
• Enrollment (Estimated): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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);
11. Clinically diagnosed stroke or TIA within 3 months prior to surgery;
12. Gastrointestinal bleeding requiring hospitalization or transfusion therapy or other clinically significant bleeding or coagulation disorders within 3 months prior to surgery, which preclude the required antiplatelet therapy in the study;
13. Comorbid with severe native coronary artery lesions that require revascularization therapy;
14. Comorbid with severe mitral or tricuspid regurgitation;
15. Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;
16. Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF <20%);
17. Comorbid with end-stage renal diseases requiring chronic dialysis;
18. Comorbid with blood dyscrasias defined as leukopenia (white blood cell count < 3×109/L), thrombocytopenia (platelet count < 50×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable states;
19. Subjects corresponding to the criteria of a vulnerable population (including patients who are unable to fully understand all aspects of the study, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment);
20. Female subjects known to be pregnant or lactating;
21. Life expectancy is less than 12 months as assessed by the investigator;
22. Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively;
23. Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR group; TAVR with the study device will be performed in the TAVR group	Device: VitaFlow Liberty; All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty
Active Comparator: SAVR group; SAVR with a commercially available surgical bioprosthetic valve will be performed in the control group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite endpoint events (all-cause mortality, all strokes, and re-hospitalizations [surgery, valve or heart failure related re-hospitalizations])	The composite endpoint event at 12 months postoperatively refers to all-cause mortality, all strokes, and re-hospitalizations related to procedure, valve or heart failure that occur within 12 months postoperatively.	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Device success is defined as meeting all the following criteria: Correct positioning of a single prosthetic heart valve into the proper anatomical location;; Successful access, delivery of the device, and retrieval of the delivery system;; Freedom from mortality;; Freedom from surgery or intervention related to the devicea or to a major vascular or access-related or cardiac structural complication;; Intended performance of the valvec (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation).	30 days postoperatively
Prosthetic valve performance evaluation	The prosthetic valve performance will be evaluated independently by the corelab based on the echocardiography.	30 days, 6 months, 12 months, 2-5 years postoperatively
New York Heart Association grading assessment of cardiac function	New York Heart Association (NYHA) grading system includes four gradings with higher grading means severer outcome.	Discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively
Quality of life assessment (Kansas City Cardiomyopathy Questionnaire score)	Kansas City Cardiomyopathy Questionnaire (KCCQ) score is ranged from 0 to 100 with higher score means better quality of life.	30 days, 6 months, 12 months postoperatively
All-cause mortality	According to the VARC3 criteria, all-cause mortality includes cardiovascular mortality and non-cardiovascular mortality.	30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of all strokes	According to the VARC3 criteria, all strokes include ischemic strokes (including TIAs), hemorrhagic strokes, and unspecified strokes, as well as disabling and non-disabling strokes.	30 days, 6 months, 12 months, 2 to 5 years postoperatively
Incidence of myocardial infarction	Myocardial infarction in this study is defined according to the VARC3 criteria.	Discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE)	MACCE includes all-cause mortality, myocardial infarction, all strokes, and reoperation due to valvular dysfunction, with each event defined according to the VARC3 criteria.	30 days, 6 months, 12 months postoperatively
Incidence of life-threatening or disabling major bleeding	Life-threatening or disabling major bleeding is defined as types 3 and 4 bleeding according to the VARC3 criteria.	30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of acute kidney injury (AKI)	According to the VARC3 criteria, AKI is defined as stages 2-4 acute kidney injury.	Discharge, 30 days postoperatively
Incidence of conduction disturbance and arrhythmias	Conduction disturbance and arrhythmias are defined according to the VARC3 criteria.	30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of serious vascular complications	Serious vascular complications are defined according to the VARC3 criteria.	30 days, 6 months, 12 months postoperatively
Incidence of permanent pacemaker implantation	Defined as the percentage of subjects with newly permanent pacemaker implantation occurring after surgery among all subjects enrolled in each group.	30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of other TAVR-related complications	Other TAVR-related complications include: conversion to surgery, unplanned cardiopulmonary mechanical assistance, coronary artery occlusion requiring intervention, ventricular septal perforation, mitral valve damage or dysfunction, cardiac tamponade, endocarditis, valvular thrombosis, valvular dyslocation (displacement, embolization, false release), and reoperation due to valve dysfunction (including surgical or interventional therapy).	Immediately, 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of Bioprosthetic valve dysfunction (BVD)	BVD includes structural valve deterioration (SVD), moderate and severe prosthesis-patient mismatch (PPM), moderate and severe paravalvular leak (PVL), thrombosis or endocarditis.	12 months, 2-5 years postoperatively
Moderate to severe structural valvular deterioration (HVD)	Moderate HVD is defined as an increase in mean transvalvular gradient ≥ 10mmHg resulting in mean gradient ≥ 20mmHgc with concomitant decrease in EOA ≥ 0.3cm2 or ≥ 25% and/or decrease in Doppler velocity index ≥ 0.1 or ≥ 20% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence or increase of ≥ 1 graded of intraprosthetic AR resulting in ≥ moderate AR. Severe HVD is defined as an increase in mean transvalvular gradient ≥ 20mmHg resulting in mean gradient ≥ 30mmHgc with concomitant decrease in EOA ≥ 0.6cm2 or ≥50% and/or decrease in Doppler velocity index ≥0.2 or ≥40% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence, or increase of ≥ 2 grades,d of intraprosthetic AR resulting in severe AR	12 months, 2-5 years postoperatively
Bioprosthetic valve dysfunction (BVF)	BVF is a composite endpoint, including severe HVD, aortic valve reintervention, and valve-related mortality (investigator assessment).	12 months, 2-5 years postoperatively
Re-hospitalization related to procedure, valve or heart failure	Re-hospitalization related to procedure, valve or heart failure is defined according to the VARC3 criteria.	30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of adverse events (AEs)	An AE is an untoward medical occurrence during the course of the clinical study, regardless of whether or not related to the study device	throughout the clinical study period
Incidence of serious adverse events (SAEs)	Serious adverse event (SAE) refers to any adverse event that occurs during the clinical study of a medical device that results in any of the following: Leads to death, or; Leads to serious deterioration of the health conditions, including:Fatal disease or injury Permanent defect in the physical structure or physical function Requiring hospitalization or prolongation of hospital stay Any event which requires medical or surgical intervention to prevent persistent disability/incapacity; Leads to fetal distress, fetal death or congenital abnormality or congenital defect, etc. Note: Planned hospitalizations due to pre-existing disease conditions, or events that do not result in significant deterioration in health status due to procedures required by the clinical study program are not considered SAEs.	throughout the clinical study period

Collaborators and Investigators

• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
• Collaborators: The First Affiliated Hospital of Anhui Medical University; West China Hospital; Qilu Hospital of Shandong University; People's Hospital of Xinjiang Uygur Autonomous Region; Zhejiang University; Yanan Hospital of Kunming City; Provincial Hospital of fuzhou University
• Investigators: Principal Investigator: Mao Chen, Professor, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Aortic stenosis; TAVR; SAVR; Bicuspid Aortic Valve (BAV)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bicuspid Aortic Valve Disease; Aortic Valve Stenosis
• Other Study ID Numbers: PROMIS-BAV-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No