An interventional study of VitaFlow Liberty and Commercially available surgical bioprosthetic valve in Aortic Stenosis and Bicuspid Aortic Valve (BAV), sponsored by Shanghai MicroPort CardioFlow Medtech Co., Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Not applicable, Interventional, and Treatment
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 452 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Shanghai MicroPort CardioFlow Medtech Co., Ltd. is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
TAVR with the study device will be performed in the TAVR group
Device: VitaFlow Liberty
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 TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty
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.
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.
Time frame: 12 months postoperatively
Device success rate
Device success is defined as meeting all the following criteria: 1. Correct positioning of a single prosthetic heart valve into the proper anatomical location; 2. Successful access, delivery of the device, and retrieval of the delivery system; 3. Freedom from mortality; 4. Freedom from surgery or intervention related to the devicea or to a major vascular or access-related or cardiac structural complication; 5. Intended performance of the valvec (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation).
Time frame: 30 days postoperatively
Prosthetic valve performance evaluation
The prosthetic valve performance will be evaluated independently by the corelab based on the echocardiography.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Discharge, 30 days postoperatively
Incidence of conduction disturbance and arrhythmias
Conduction disturbance and arrhythmias are defined according to the VARC3 criteria.
Time frame: 30 days, 6 months, 12 months, 2-5 years 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.
Time frame: 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.
Time frame: 30 days, 6 months, 12 months 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).
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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: 1. Leads to death, or 2. 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 3. 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.
Time frame: throughout the clinical study period
Plan to share: No
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Shanghai MicroPort CardioFlow Medtech Co., Ltd.