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NCT01756222 Clinical Trial

Bicuspid Aortic Valve (BAV) Registry

Bicuspid Aortic Valve Clinical Trial

— BAV  

Official title:
Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01756222
Other study ID # HUM00035836
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2010
Est. completion date December 2040

Study information
Verified date January 2024
Source University of Michigan
Contact Bo Yang, MD, PhD
Email boya@med.umich.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.

Description:

The purpose of this registry is to gather information on patients with bicuspid aortic valve disease. The data collected in the registry will be used to assess patterns of aortic dilation, responses to medical therapy based on serial imaging and to assess for potential genetic markers of this disease

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 2040
Est. primary completion date December 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any patient over the age of 18 who is able/willing to give informed consent with the diagnosis of bicuspid aortic valve disease, a family history of this disease or an ascending aortic aneurysm that is idiopathic can be included in the registry. Exclusion Criteria: - Patients unable or unwilling to give informed consent.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Univeristy of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterizing patients with bicuspid aortic valve disease Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention. 30 years
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