Bicuspid Aortic Valve Registry (BAV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Anna Booher, University of Michigan
ClinicalTrials.gov Identifier:
NCT01756222
First received: December 19, 2012
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition
Bicuspid Aortic Valve Disease

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 University of Michigan:

Primary Outcome Measures:
  • Characterizing patients with bicuspid aortic valve disease [ Time Frame: 30 years ] [ Designated as safety issue: No ]
    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 2040
Estimated Primary Completion Date: December 2040 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bicuspid Aortic Valve Disease Patients
Patients with the diagnosis of BAV disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756222

Contacts
Contact: Nickole Calson, BSN 734-232-4780 ngarvey@med.umich.edu

Locations
United States, Michigan
Univeristy of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nickole Carlson, BSN    734-232-4780    ngarvey@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Anna Booher, MD University of Michigan
  More Information

No publications provided

Responsible Party: Anna Booher, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01756222     History of Changes
Other Study ID Numbers: HUM00035836
Study First Received: December 19, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Bicuspid Aortic Valve Disease
Bicuspid Aortic Valve
BAV

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Defects, Congenital
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 20, 2014