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Bicuspid Aortic Valve (BAV) Registry (BAV)

This study is currently recruiting participants.
Verified June 2017 by Dr. Bo Yang, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756222
First Posted: December 25, 2012
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Bo Yang, University of Michigan
  Purpose
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.

Condition
Bicuspid Aortic Valve

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry

Resource links provided by NLM:


Further study details as provided by Dr. Bo Yang, University of Michigan:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bicuspid Aortic Valve Disease Patients
Patients with the diagnosis of BAV disease.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
Contact: Jennifer L McNamara, MS 734-2324779 jlmcnama@med.umich.edu

Locations
United States, Michigan
Univeristy of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennifer L McNamara, MS    734-232-4779    jlmcnama@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Bo Yang, MD University of Michigan
  More Information

Responsible Party: Dr. Bo Yang, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01756222     History of Changes
Other Study ID Numbers: HUM00035836
First Submitted: December 19, 2012
First Posted: December 25, 2012
Last Update Posted: June 26, 2017
Last Verified: June 2017
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:
Heart Valve Diseases
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction