NCT06802016

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2025Dec 2035

Study Start

First participant enrolled

January 18, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 25, 2025

Last Update Submit

January 30, 2025

Conditions

Bicuspid Aortic Valve (BAV)

Keywords

Bicuspid Aortic ValveDilated ascending aortaAortic regurgitationAortic stenosisAcoustic cardiography

Outcome Measures

Primary Outcomes (1)

  • SAVR / TAVR

    Indications for surgical or transcatheter aortic valve replacement

    5 year

Secondary Outcomes (1)

  • Major adverse cardiovascular events(MACE)

    5 year

Other Outcomes (2)

  • Synchronized analysis of phonocardiogram and electrocardiogram

    6 or 12 month depending on severity of valves

  • Echocardiography

    6 or 12 month depending on severity of valves

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample at enrollment

MeSH Terms

Conditions

Bicuspid Aortic Valve DiseaseAortic Valve InsufficiencyAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentricular Outflow Obstruction

Study Officials

  • Zhengbin Zhu, MD, PhD

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Wenli Zhang, MD

CONTACT

+86 (021)64370045zwl11929@rjh.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy chief physician

Study Record Dates

First Submitted

January 25, 2025

First Posted

January 30, 2025

Study Start

January 18, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2035

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

CN(1)