An International Registry for Data and Imaging of Children with Congenital Bicuspid Aortic Valve Disease
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Donald Hagler, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available