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Bicuspid Aortic Valve (BAV) Registry

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT01756222
Collaborator
(none)
5,000
Enrollment
1
Location
248
Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry
    Study Start Date :
    Apr 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Bicuspid Aortic Valve Disease Patients

    Patients with the diagnosis of BAV disease.

    Outcome Measures

    Primary Outcome Measures

    1. Characterizing patients with bicuspid aortic valve disease [30 years]

      Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univeristy of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Bo Yang, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Bo Yang, MD, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01756222
    Other Study ID Numbers:
    • HUM00035836
    First Posted:
    Dec 25, 2012
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Dr. Bo Yang, MD, University of Michigan
    Bicuspid Aortic Valve Disease
    Bicuspid Aortic Valve
    BAV
    Additional relevant MeSH terms:
    Bicuspid Aortic Valve Disease
    Heart Valve Diseases

    Study Results

    No Results Posted as of Jan 10, 2022