NCT01823432|Completed
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Sponsor study identifier
observational
454
1 country
1
Study Start
March 2012
Actual (reported)Primary Completion
September 19, 2022
Actual (reported)Study Completion
September 19, 2022
Actual (reported)Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 19, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Actual (reported)March 27, 2013
Actual (reported)April 4, 2013
Actual (reported)September 19, 2022
Actual (reported)September 19, 2022
Actual (reported)Thoracic aortic aneurysms and dissections
Development of new aneurysms and/or dissections of the thoracic aorta
10 years
Aortic valve replacement surgery
10 years
Aortic enlargement
10 years
Aortic valve degeneration
10 years
Patients with bicuspid or unicuspid aortic valves, regardless of surgical status.
Adults at least 18 years old with unicuspid or bicuspid aortic valves
University of Texas Health Science Center Houston
Houston, Texas, 77030, United States
DiGregorio H, Mansoorshahi S, Carlisle SG, Tovar Pensa C, Watts A, McNeely C, Sabate-Rotes A, Yetman A, Michelena HI, De Backer JFA, Mosquera LM, Bissell MM, Andreassi MG, Foffa I, Hui DS, Caffarelli A, Kim YY, Citro R, De Marco M, Tretter JT, McBride KL, Body SC, Milewicz DM, Prakash SK; EBAV Investigators. Contribution of rare chromosome 22q11.2 copy number variants to non-syndromic bicuspid aortic valve. Heart. 2025 Feb 12;111(5):221-229. doi: 10.1136/heartjnl-2024-324669.
Genomic DNA from whole blood Genomic DNA from saliva Aortic valve tissue preserved in RNALater
Siddharth Prakash, MD, PhD
The University of Texas Health Science Center, Houston
454 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2013
First Posted
April 4, 2013
Study Start
March 2012
Actual (reported)Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Contact the study team to confirm eligibility.
Primary Completion
September 19, 2022
Actual (reported)Study Completion
September 19, 2022
Actual (reported)Last Updated
September 21, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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