Aortic StenosisPROMIS-BAVNCT06597188
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
A study testing VitaFlow Liberty and Commercially available surgical bioprosthetic valve in people with Aortic Stenosis and Bicuspid Aortic Valve (BAV), run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Stenosis, Bicuspid Aortic Valve (BAV)
- What is being tested?
- VitaFlow Liberty and Commercially available surgical bioprosthetic valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 30 Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged ≤ 75 years;
- 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；
- New York Heart Association (NYHA) cardiac function classification ≥ Class II;
- With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
- Voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Known allergy or resistance to study device and control device components such as nitinol or contrast media;
- Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
- Known presence of active infective endocarditis or other active infection;
- Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
- Ascending aorta width ≥50mm;
- Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
Show all 23Show fewer
- 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);
- Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
- Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery;
- Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation);
- Clinically diagnosed stroke or TIA within 3 months prior to surgery;
- 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;
- Comorbid with severe native coronary artery lesions that require revascularization therapy;
- Comorbid with severe mitral or tricuspid regurgitation;
- Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;
- Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF <20%);
- Comorbid with end-stage renal diseases requiring chronic dialysis;
- 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;
- 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);
- Female subjects known to be pregnant or lactating;
- Life expectancy is less than 12 months as assessed by the investigator;
- Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively;
- Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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)
- Being tested
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Keywords
- Aortic stenosis, Bicuspid Aortic Valve (BAV), TAVR, SAVR
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaFlow LibertyDevice
All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty
Commercially available surgical bioprosthetic valveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TAVR group | Experimental | TAVR with the study device will be performed in the TAVR group Receives: Device: VitaFlow Liberty |
| SAVR group | Active comparator | SAVR with a commercially available surgical bioprosthetic valve will be performed in the control group Receives: Device: Commercially available surgical bioprosthetic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months postoperatively
Secondary outcomes (20)
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).
Measured: 30 days postoperatively
Prosthetic valve performance evaluation
The prosthetic valve performance will be evaluated independently by the corelab based on the echocardiography.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Discharge, 30 days postoperatively
Incidence of conduction disturbance and arrhythmias
Conduction disturbance and arrhythmias are defined according to the VARC3 criteria.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: throughout the clinical study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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, Fuzhou University Affiliated Provincial Hospital, Yan'an Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
- Investigators
- Mao Chen, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597188
- Sponsor's protocol ID
- PROMIS-BAV-2024
- Acronym
- PROMIS-BAV
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06597188
- Acronym / sponsor ID
- PROMIS-BAV / PROMIS-BAV-2024
- Conditions
- Aortic Stenosis, Bicuspid Aortic Valve (BAV)
- Keywords
- Aortic stenosis, Bicuspid Aortic Valve (BAV), TAVR, SAVR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- 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, Fuzhou University Affiliated Provincial Hospital, Yan'an Affiliated Hospital of Kunming Medical University
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR group | Experimental | Device: VitaFlow LibertyTAVR with the study device will be performed in the TAVR group |
| SAVR group | Active comparator | Device: Commercially available surgical bioprosthetic valveSAVR with a commercially available surgical bioprosthetic valve will be performed in the control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject aged ≤ 75 years;
- 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；
- New York Heart Association (NYHA) cardiac function classification ≥ Class II;
- With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
- Voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (23 listed)
- Known allergy or resistance to study device and control device components such as nitinol or contrast media;
- Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
- Known presence of active infective endocarditis or other active infection;
- Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
- Ascending aorta width ≥50mm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaFlow LibertyAll subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty | Device | TAVR group |
| Commercially available surgical bioprosthetic valveAll subjects randomized to the SAVR group will receive surgical aortic valve replacement (SAVR) with the control device of a commercially available surgical bioprosthetic valve. | Device | SAVR group |
Primary outcome
Incidence of composite endpoint events (all-cause mortality, all strokes, and re-hospitalizations [surgery, valve or heart failure related re-hospitalizations])
Time frame: 12 months postoperatively
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.
20 secondary outcomes
Device success rate
Time frame: 30 days postoperatively
Prosthetic valve performance evaluation
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
New York Heart Association grading assessment of cardiac function
Time frame: Discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively
Quality of life assessment (Kansas City Cardiomyopathy Questionnaire score)
Time frame: 30 days, 6 months, 12 months postoperatively
All-cause mortality
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of all strokes
Time frame: 30 days, 6 months, 12 months, 2 to 5 years postoperatively
Incidence of myocardial infarction
Time frame: Discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 30 days, 6 months, 12 months postoperatively
Incidence of life-threatening or disabling major bleeding
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of acute kidney injury (AKI)
Time frame: Discharge, 30 days postoperatively
Incidence of conduction disturbance and arrhythmias
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of permanent pacemaker implantation
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of serious vascular complications
Time frame: 30 days, 6 months, 12 months postoperatively
Incidence of other TAVR-related complications
Time frame: Immediately, 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of Bioprosthetic valve dysfunction (BVD)
Time frame: 12 months, 2-5 years postoperatively
Moderate to severe structural valvular deterioration (HVD)
Time frame: 12 months, 2-5 years postoperatively
Bioprosthetic valve dysfunction (BVF)
Time frame: 12 months, 2-5 years postoperatively
Re-hospitalization related to procedure, valve or heart failure
Time frame: 30 days, 6 months, 12 months, 2-5 years postoperatively
Incidence of adverse events (AEs)
Time frame: throughout the clinical study period
Incidence of serious adverse events (SAEs)
Time frame: throughout the clinical study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mao Chen, Professor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaFlow Liberty and Commercially available surgical bioprosthetic valve in people with Aortic Stenosis and Bicuspid Aortic Valve (BAV), run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite endpoint events (all-cause mortality, all strokes, and re-hospitalizations [surgery, valve or heart failure related re-hospitalizations]) (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.