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NCT Number: NCT06802016

A Study of Chinese 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.

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Wenli Zhang, MD

CONTACT

[email protected]

+86 64370045

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. SAVR / TAVR

    Time frame: 5 year

    Indications for surgical or transcatheter aortic valve replacement

Secondary outcomes

  1. Major adverse cardiovascular events(MACE)

    Time frame: 5 year

    Ascending aortic aneurysm or aortic dissection, all-cause death, cardiac death, non-fatal stroke, hospitalization for heart failure

Other outcomes

  1. Synchronized analysis of phonocardiogram and electrocardiogram

    Time frame: 6 or 12 month depending on severity of valves

    Synchronized PCG and ECG data using a wearable cardiac monitoring patch

  2. Echocardiography

    Time frame: 6 or 12 month depending on severity of valves

    Valve 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenli Zhang, MD

CONTACT

[email protected]

+86 (021)64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Cohort Study of Congenital Bicuspid Aortic Valve

Important dates

Study start
2025
Primary completion
2029
Study completion
2035
First posted
Jan 30, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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