Actively Recruiting
A Cohort Study of Congenital Bicuspid Aortic Valve
Led by Ruijin Hospital · Updated on 2025-02-03
500
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating congenital bicuspid aortic valve (BAV), a heart condition that may be more common in China than previously recognized. This observational study aims to analyze gene backgrounds, disease progression, and imaging features of young people with BAV, along with their long-term health outcomes. The study hopes to identify individuals at higher risk based on specific gene expression or other clinical characteristics. The study follows a cohort of participants aged 14 to 60 years who have a confirmed diagnosis of BAV through imaging methods such as echocardiography or cardiac magnetic resonance. Participants will be observed over time without receiving experimental treatments. The study will monitor disease progression, including the need for surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) over a five-year period. Participants will undergo regular follow-up visits to assess heart health and disease status using imaging and clinical evaluations. The study will track major adverse cardiovascular events (MACE) during the five years. Researchers will collect data on patient outcomes, disease progression, and treatment interventions. The total participation duration extends across several years to capture long-term follow-up information.
CONDITIONS
Brief Title
A Study of Chinese Congenital Bicuspid Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 14 to 60 years
- Confirmed diagnosis of bicuspid aortic valve by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)
- Patients informed about the study and agreed to participate by signing an approved consent form
You will not qualify if you...
- Poor compliance and inability to complete required follow-up visits
- Rheumatic heart valve disease or other organic valve diseases
- Hyperthyroidism, severe anemia, or other conditions that significantly affect hemodynamics
- Other reasons as determined by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment period
Participants undergo imaging evaluations such as echocardiography, aortic CTA, and cardiac magnetic resonance to confirm and characterize bicuspid aortic valve.
1 to 2 visits depending on imaging needs
Duration - Up to 5 years
Participants are followed over several years to observe gene backgrounds, pathological progress, and clinical outcomes.
Regular follow-up visits for assessments over 5 years
Trial Site Locations
Total: 1 location
1
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Wenli Zhang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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