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International Bicuspid Aortic Valve Consortium (BAVCon)

NCT01980797 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 6464

Last updated 2026-04-01

No results posted yet for this study

Summary

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in \>50% of BAV patients, and accounts for \~40% of the \>30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

The Specific Aims of this study are:

1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.
2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

Conditions

  • Bicuspid Aortic Valve Disease
  • Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Simon C. Body, MD, MPH · Boston University School of Medicine, Anesthesiology Department

Eligibility

Min Age
8 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • United States
  • Canada
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980797 on ClinicalTrials.gov