International Bicuspid Aortic Valve Consortium (BAVCon) (BAVCon)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01980797|
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : November 11, 2013
Last Update Posted : May 6, 2020
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|
|Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|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|
Bicuspid aortic valve disease
Group/Cohort Label - Bicuspid aortic valve
Group/Cohort Description -
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.
- 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
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|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Quebec City, Quebec, Canada, G1V 4G5|
|Istituto Policlinico San Donato|
|San Donato Milanese, Milan, Italy, 20097|
|Naples, Italy, 80100|
|Second University of Naples|
|Naples, Italy, 80131|
|University of Salerno|
|Salerno, Italy, 36-83023|
|Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|University of Oxford|
|Oxford, United Kingdom, OX3 9DU|
|Principal Investigator:||Simon C. Robson, MD, PhD||Beth Israel Deaconess Medical Center|