NCT01980797|Active Not Recruiting
International Bicuspid Aortic Valve Consortium (BAVCon)
BAVCon
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BAVCon
Sponsor study identifier
Secondary identifiers
observational
6,464
5 countries
12
Study Start
November 2013
Actual (reported)Primary Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Actual (reported)November 5, 2013
Actual (reported)November 11, 2013
Actual (reported)November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Bicuspid aortic valve disease
The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.
10 years
The development of thoracic aortic disease in patients with bicuspid aortic valve disease
10 years
Group/Cohort Label - Bicuspid aortic valve Group/Cohort Description - * Patients diagnosed with bicuspid aortic valve * All ages ≥8 years * Able to provide fully informed consent
Group/Cohort Label - Tricuspid aortic valve control patients Group/Cohort Description -Control patients will come from approximately matched patients without an identified bicuspid aortic valve who are trace, gender and geographically matched. * Patients not diagnosed with bicuspid aortic valve * All ages ≥8 years * Able to provide fully informed consent
Patients with and without bicuspid aortic valves disease
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02218, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Laval University
Québec, Quebec, G1V 4G5, Canada
Istituto Policlinico San Donato
San Donato Milanese, Milan, 20097, Italy
We are collecting DNA from either saliva or blood.
Simon C. Body, MD, MPH
Boston University School of Medicine, Anesthesiology Department
6,464 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2013
First Posted
November 11, 2013
Study Start
November 2013
Actual (reported)A Study of Chinese Congenital Bicuspid Aortic Valve
Contact the study team to confirm eligibility.
Monaldi Hospital
Naples, 80100, Italy
Second University of Naples
Naples, 80131, Italy
University of Salerno
Salerno, 36-83023, Italy
Hospital Vall d'Hebron
Barcelona, 08035, Spain
University of Oxford
Oxford, OX3 9DU, United Kingdom
Primary Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 1, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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