NCT01756222

Brief Summary

The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2010Dec 2040

Study Start

First participant enrolled

April 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2012

Completed
28 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

30.7 years

First QC Date

December 19, 2012

Last Update Submit

January 14, 2025

Conditions

Bicuspid Aortic Valve

Keywords

Bicuspid Aortic Valve DiseaseBicuspid Aortic ValveBAV

Outcome Measures

Primary Outcomes (1)

  • Characterizing patients with bicuspid aortic valve disease

    Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.

    30 years

Study Arms (1)

Bicuspid Aortic Valve Disease Patients

Patients with the diagnosis of BAV disease.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary clinic

You may qualify if:

  • 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.

You may not qualify if:

  • Patients unable or unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bo Yang, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Yang, MD, PhD

CONTACT

boya@med.umich.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 25, 2012

Study Start

April 1, 2010

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

US(1)