A Study of Chinese Congenital Bicuspid Aortic Valve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bicuspid Aortic Valve (BAV). Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Cohort Study of Congenital Bicuspid Aortic Valve
Overview
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.
Primary outcome measures
- SAVR / TAVR [Time frame: 5 year]
Secondary outcome measures (1)
- Major adverse cardiovascular events(MACE) [Time frame: 5 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin hospital, Shanghai JiaoTong University School of Medicine — Shanghai
Identifiers
NCT: NCT06802016 · RJH-BAV