A Study of Chinese Congenital Bicuspid Aortic Valve

A Cohort Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Bicuspid Aortic Valve (BAV)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Wenli Zhang, MD; Phone Number: +86 (021)64370045; Email: zwl11929@rjh.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Wenli Zhang, MD; Phone Number: +86 64370045; Email: zwl11929@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This is single-center cohort study. Patients diagnosed with BAV were enrolled in Ruijin Hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAVR / TAVR	Indications for surgical or transcatheter aortic valve replacement	5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events(MACE)	Ascending aortic aneurysm or aortic dissection, all-cause death, cardiac death, non-fatal stroke, hospitalization for heart failure	5 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Synchronized analysis of phonocardiogram and electrocardiogram	Synchronized PCG and ECG data using a wearable cardiac monitoring patch	6 or 12 month depending on severity of valves
Echocardiography	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.	6 or 12 month depending on severity of valves

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Zhengbin Zhu, MD, PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Aortic stenosis; Aortic regurgitation; Bicuspid Aortic Valve; Dilated ascending aorta; Acoustic cardiography
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Bicuspid Aortic Valve Disease; Heart Valve Diseases
• Other Study ID Numbers: RJH-BAV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No