Bicuspid Aortic ValveBAVNCT01756222
Bicuspid Aortic Valve (BAV) Registry
An observational study of Bicuspid Aortic Valve, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bicuspid Aortic Valve
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2040
- How long will I take part?
- 30 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary clinic
Who may be able to join
- 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.
Who cannot join
- Patients unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.
Read the 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
- Conditions
- Bicuspid Aortic Valve
- Keywords
- Bicuspid Aortic Valve Disease, Bicuspid Aortic Valve, BAV
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bicuspid Aortic Valve Disease Patients | Patients with the diagnosis of BAV disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterizing patients with bicuspid aortic valve disease
Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bo Yang, University of Michigan
- Investigators
- Bo Yang, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756222
- Sponsor's protocol ID
- HUM00035836
- Acronym
- BAV
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2012
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided