Bicuspid Aortic Valve (BAV)NCT06802016
A Study of Chinese Congenital Bicuspid Aortic Valve
An observational study of Bicuspid Aortic Valve (BAV), run by Ruijin Hospital at 1 site in China.
Trial summary
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Bicuspid Aortic Valve (BAV)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2025to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This is single-center cohort study. Patients diagnosed with BAV were enrolled in Ruijin Hospital.
Who may be able to join
- The patients were aged 14-60 years;
- Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)
- Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee.
Who cannot join
- Poor patient compliance and inability to complete follow-up visits as required;
- Rheumatic heart valve disease, other organic valve disease.
- Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics.
- Other circumstances that the researcher believes should be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Wenli Zhang, MD, +86 64370045, zwl11929@rjh.com.cn
About this study
Official title: A Cohort Study of Congenital Bicuspid Aortic Valve
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes.
Read the detailed description
There is no recognized comprehensive epidemiological data on congenital BAV in China, although findings of BAV is common in clinical practice. In the course of the Venus-A registry clinical study, which was the first Aortic Valve Replacement (TAVR) trial in China, the investigators concluded about 40% of the final enrollment of BAV patients. Since then, an increasing number of scholars have figured out that the prevalence of BAV may be much higher in China than abroad. This study was designed to investigate Gene backgrounds, pathological progress, imaging characteristics of young health BAV participants and their relationships in long-term follow-up. These findings may help to identify high risk individuals with specific gene expression or other features in clinical observation.
- Conditions
- Bicuspid Aortic Valve (BAV)
- Keywords
- Bicuspid Aortic Valve, Dilated ascending aorta, Aortic regurgitation, Aortic stenosis, Acoustic cardiography
- Medical subject headings
- Bicuspid Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
SAVR / TAVR
Indications for surgical or transcatheter aortic valve replacement
Measured: 5 year
Secondary outcomes (1)
Major adverse cardiovascular events(MACE)
Ascending aortic aneurysm or aortic dissection, all-cause death, cardiac death, non-fatal stroke, hospitalization for heart failure
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start18 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic Valve (BAV)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu zhengbin, Ruijin Hospital
- Investigators
- Zhengbin Zhu, MD, PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802016
- Sponsor's protocol ID
- RJH-BAV
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Congenital Bicuspid Aortic Valve
- ClinicalTrials.gov ID
- NCT06802016
- Acronym / sponsor ID
- RJH-BAV
- Conditions
- Bicuspid Aortic Valve (BAV)
- Keywords
- Bicuspid Aortic Valve, Dilated ascending aorta, Aortic regurgitation, Aortic stenosis, Acoustic cardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 30 Jan 2025 (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.
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes.
Detailed description
There is no recognized comprehensive epidemiological data on congenital BAV in China, although findings of BAV is common in clinical practice. In the course of the Venus-A registry clinical study, which was the first Aortic Valve Replacement (TAVR) trial in China, the investigators concluded about 40% of the final enrollment of BAV patients. Since then, an increasing number of scholars have figured out that the prevalence of BAV may be much higher in China than abroad. This study was designed to investigate Gene backgrounds, pathological progress, imaging characteristics of young health BAV participants and their relationships in long-term follow-up. These findings may help to identify high risk individuals with specific gene expression or other features in clinical observation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This is single-center cohort study. Patients diagnosed with BAV were enrolled in Ruijin Hospital.
Key inclusion criteria (3 listed)
- The patients were aged 14-60 years;
- Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)
- Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee.
Key exclusion criteria (4 listed)
- Poor patient compliance and inability to complete follow-up visits as required;
- Rheumatic heart valve disease, other organic valve disease.
- Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics.
- Other circumstances that the researcher believes should be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SAVR / TAVR
Time frame: 5 year
Indications for surgical or transcatheter aortic valve replacement
1 secondary outcome
Major adverse cardiovascular events(MACE)
Time frame: 5 year
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 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Zhengbin Zhu, MD, PhD study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid Aortic Valve (BAV), run by Ruijin Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Feb 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?
Contact Wenli Zhang, MD (+86 (021)64370045, zwl11929@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAVR / TAVR (time frame: 5 year). 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 3 Feb 2025.