International Bicuspid Aortic Valve Consortium (BAVCon) (BAVCon)
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ClinicalTrials.gov Identifier: NCT01980797 |
Recruitment Status :
Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : May 9, 2022
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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:
- To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.
- 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.
Condition or disease |
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Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 10000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 20 Years |
Official Title: | International Bicuspid Aortic Valve Consortium (BAVCon) |
Study Start Date : | November 2013 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2033 |
Group/Cohort |
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Bicuspid aortic valve disease
Group/Cohort Label - Bicuspid aortic valve Group/Cohort Description -
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Tricuspid aortic valve control patients
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.
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- Bicuspid aortic valve disease [ Time Frame: 10 years ]The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.
- The development of thoracic aortic disease in patients with bicuspid aortic valve disease [ Time Frame: 10 years ]The second specific aim is to identify genetic and non-genetic factors to cause thoracic aortic disease in BAV patients.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 8 Years to 90 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients diagnosed as having a bicuspid aortic valve
- All ages ≥8 years
- Able to provide fully informed consent
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980797
United States, Massachusetts | |
Tufts Medical Center | |
Boston, Massachusetts, United States, 02111 | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02218 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas Health Science Center at Houston | |
Houston, Texas, United States, 77030 | |
Canada, Quebec | |
Laval University | |
Quebec City, Quebec, Canada, G1V 4G5 | |
Italy | |
Istituto Policlinico San Donato | |
San Donato Milanese, Milan, Italy, 20097 | |
Monaldi Hospital | |
Naples, Italy, 80100 | |
Second University of Naples | |
Naples, Italy, 80131 | |
University of Salerno | |
Salerno, Italy, 36-83023 | |
Spain | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
United Kingdom | |
University of Oxford | |
Oxford, United Kingdom, OX3 9DU |
Principal Investigator: | Simon C. Body, MD, MPH | Boston University School of Medicine, Anesthesiology Department |
Responsible Party: | Boston University |
ClinicalTrials.gov Identifier: | NCT01980797 |
Other Study ID Numbers: |
H-39760 1R21HL150373-01 ( U.S. NIH Grant/Contract ) |
First Posted: | November 11, 2013 Key Record Dates |
Last Update Posted: | May 9, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bicuspid aortic valve disease Thoracic aortic disease Genetics |
Echocardiography Cardiac CT Cardiac MRI |
Aortic Valve Disease Heart Valve Diseases Bicuspid Aortic Valve Disease Aortic Diseases Heart Diseases |
Cardiovascular Diseases Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Vascular Diseases |