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Bicuspid Aortic Valve (BAV) Registry (BAV)

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ClinicalTrials.gov Identifier: NCT01756222
Recruitment Status : Recruiting
First Posted : December 25, 2012
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Bo Yang, University of Michigan

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

Condition or disease
Bicuspid Aortic Valve

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry
Study Start Date : April 2010
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Group/Cohort
Bicuspid Aortic Valve Disease Patients
Patients with the diagnosis of BAV disease.



Primary Outcome Measures :
  1. Characterizing patients with bicuspid aortic valve disease [ Time Frame: 30 years ]
    Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756222


Contacts
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Contact: Jeffrey Clemence, MS 734-232-4779 jeffclem@med.umich.edu

Locations
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United States, Michigan
Univeristy of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jeffrey Clemence    734-232-4779    jeffclem@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Bo Yang, MD University of Michigan
Additional Information:

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Responsible Party: Dr. Bo Yang, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01756222    
Other Study ID Numbers: HUM00035836
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. Bo Yang, University of Michigan:
Bicuspid Aortic Valve Disease
Bicuspid Aortic Valve
BAV
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases