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A Study of Chinese Congenital Bicuspid Aortic Valve

A Cohort Study of Congenital Bicuspid Aortic Valve

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06802016
Enrollment
500
Registered
2025-01-30
Start date
2025-01-18
Completion date
2035-12-31
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bicuspid Aortic Valve (BAV)

Keywords

Bicuspid Aortic Valve, Dilated ascending aorta, Aortic regurgitation, Aortic stenosis, Acoustic cardiography

Brief 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.

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.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
SAVR / TAVR5 yearIndications for surgical or transcatheter aortic valve replacement

Secondary

MeasureTime frameDescription
Major adverse cardiovascular events(MACE)5 yearAscending aortic aneurysm or aortic dissection, all-cause death, cardiac death, non-fatal stroke, hospitalization for heart failure

Other

MeasureTime frameDescription
Synchronized analysis of phonocardiogram and electrocardiogram6 or 12 month depending on severity of valvesSynchronized PCG and ECG data using a wearable cardiac monitoring patch
Echocardiography6 or 12 month depending on severity of valvesValve morphology, Degree of valve stenosis or regurgitation, Degree of widening of the ascending aorta, Left ventricular ejection fraction(LVEF) changes, Degree of left ventricular hypertrophy or enlargement.

Countries

China

Contacts

Primary ContactWenli Zhang, MD
zwl11929@rjh.com.cn+86 (021)64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026