An International Registry for Data and Imaging of Children with Congenital Bicuspid Aortic Valve Disease

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-009989
    Sponsor Protocol Number: 14-009989

About this study

The purpose of this registry is to collect data and imagery, to study children and adults under the age of 21 who were born with bicuspid aortic valve disease. Some types of bicuspid aortic valves might be more likely associated with greater disease severity such as the degree of stenosis or valve leakage and possible enlargement of the aorta.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Age 0-21 years
  • Identified as having a bicuspid aortic valve by echocardiographic, CT or MRI
    • Criteria will be included in the data repository for the BAVCon limited dataset
    • BAVCon will modify their protocol for a pediatric core

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Donald Hagler, M.D.

Closed for enrollment

Contact information:

Cheryl Wasson R.N.

(507)255-0876

Wasson.Cheryl@mayo.edu