- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01756222
Bicuspid Aortic Valve (BAV) Registry (BAV)
January 2, 2024 updated by: Dr. Bo Yang, University of Michigan
Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.
Study Overview
Status
Recruiting
Conditions
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
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bo Yang, MD, PhD
- Email: boya@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- Univeristy of Michigan
-
Contact:
- Bo Yang, MD, PhD
- Email: boya@med.umich.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Primary clinic
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Bicuspid Aortic Valve Disease Patients
Patients with the diagnosis of BAV disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterizing patients with bicuspid aortic valve disease
Time Frame: 30 years
|
Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.
|
30 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Yang, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Estimated)
December 1, 2040
Study Completion (Estimated)
December 1, 2040
Study Registration Dates
First Submitted
December 19, 2012
First Submitted That Met QC Criteria
December 19, 2012
First Posted (Estimated)
December 25, 2012
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00035836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bicuspid Aortic Valve
-
Boston UniversityNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingBicuspid Aortic Valve Disease | Thoracic Aortic Disease in Patients With a Bicuspid Aortic ValveUnited States, Spain, United Kingdom, Canada, Italy
-
Oregon Health and Science UniversityUniversity of Colorado, Denver; Baylor College of Medicine; University of California... and other collaboratorsCompleted
-
St. George's Hospital, LondonCompletedThoracic Aortic Aneurysm | Bicuspid Cardiac ValveUnited Kingdom
-
National University of Ireland, Galway, IrelandKarolinska University Hospital; Galway University Hospitals; Kerckhoff Heart... and other collaboratorsEnrolling by invitationAortic Stenosis | Transcatheter Aortic Valve Replacement | Bicuspid Aortic Valve | Transcatheter Aortic Valve ImplantationSweden, Ireland, Germany
-
Institut für Pharmakologie und Präventive MedizinEdwards LifesciencesRecruitingAortic Stenosis With Bicuspid ValveItaly
-
Clinique PasteurUnknownBicuspid Aortic ValveFrance
-
The University of Texas Health Science Center,...CompletedBicuspid Aortic Valve | Unicuspid Aortic ValveUnited States
-
University Hospitals, LeicesterRecruiting
-
University of CataniaNot yet recruitingAortic Stenosis | Bicuspid-related AortopathyItaly
-
University of MichiganRecruitingCardiovascular Diseases | Heart Failure | Aortic Aneurysm | Aortic Dissection | Bicuspid Aortic Valve (BAV)United States