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TRAjectory of Natural Progression in Bicuspid Aortic Valve: A Multidimensional Cohort Study with Integrated Retrospective-Prospective Design (TRANSIT-BAV)

Cohort Study on the Natural Course of Bicuspid Aortic Valve Malformation - TRANSIT-BAV

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102134
Enrollment
Unknown
Registered
2025-05-09
Start date
2024-07-01
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Bicuspid aortic valve

Interventions

BAV Pathology Group (Cross-sectional Study):None
TAV Pathology Group (Cross-sectional Study):None
BAV Cohort (Cohort Study):None
TAV Cohort (Cohort Study):None
BAV CTA Cohort:None
TAV CTA Cohort:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Cross-sectional Study Participants diagnosed with ''bicuspid aortic valve (BAV)'' from the echocardiography database were retrospectively included, and their initial ltrasound records were extracted. Based on the presence or absence of valvular and ascending aortic pathologies, they were divided into a pathology group and a non-pathology group, with a ratio of approximately 7:1. Furthermore, early-stage pathology participants (mild or moderate pathologies) from the pathology group were identified. Using a greedy matching algorithm, tricuspid aortic valve (TAV) outpatients with early-stage pathologies (mild or moderate) were matched 1:1 based on gender, type and severity of aortic valve disease, and ascending aortic diameter through propensity score matching. 2. Cohort Study BAV Group Participants with BAV and documented aortic valve or ascending aortic pathology from the echocardiography database, who had multiple ultrasound visits with intervals exceeding 1year, were included. Participants with computed tomography angiography (CTA) and a necessity for CTA follow-up (e.g., dilated ascending aorta, coronary artery disease, post-non-valvular cardiac surgery) were selected for the CTA follow-up cohort. Control group Based on the categories and severity of aortic valve and ascending aortic pathologies, as well as sex, propensity score matching was performed using a greedy matching algorithm in a 1:1 ratio to select TAV participants as the control group for this cohort study.

Exclusion criteria

Exclusion criteria: 1. Age below 18 years; 2. Presence of other congenital heart diseases; 3. Prior structural heart surgery; 4. Primary pathologies of the mitral or tricuspid valves; 5. Infective endocarditis.

Design outcomes

Primary

MeasureTime frame
Clinical endpoint indicators (All-cause mortality, cardiac mortality, surgical intervention, and rehospitalization);

Secondary

MeasureTime frame
Echocardiography-related indicators (peak transvalvular velocity, mean transvalvular pressure gradient, and other cardiac structural and hemodynamic parameters);CT-related indicators (valvular calcification, fibrosis, etc.) ;Symptoms and newly developed comorbidities;Laboratory blood test indicators (including but not limited to liver function tests, renal function tests, lipid panels, etc.);

Countries

China

Contacts

Public ContactOu Yuanweixiang

West China Hospital of Sichuan University

516682916@qq.com+86 193 8215 3625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026