Bicuspid Valve Aortopathy Feasibility Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:9/21/2018
Start Date:July 2013
End Date:October 4, 2017

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Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study

In order to determine the effectiveness of medical therapy options to prevent enlargement of
the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This
feasibility study will gather accurate data on number needed to screen, changes in medication
use over time, and variance of the intended study endpoint.

The study will consider all patients with a bicuspid aortic valve and 1) determine the number
of patients needed to be screened for a clinical trial, based on patient eligibility
percentages applying specific inclusion and exclusion criteria, 2) for those meeting these
criteria, follow changes in and compliance with medical therapy over two years, and 3) in a
limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the
change in aortic area over time.

Inclusion Criteria:

- Bicuspid aortic valve

- Aortic measurement of 35 - 49 mm on prior imaging study

Exclusion Criteria:

- Prior aortic valve or thoracic aortic surgery

- Prior aortic dissection

- Other condition associated with enlarged aorta including Coarctation, Marfans, Turner
syndrome, Loeys-Dietz, etc.

- Severe aortic stenosis or regurgitation

- Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator

- Anticipated pregnancy, surgery, or move outside the area within 2 years
We found this trial at
6
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Denver, Colorado 80210
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Denver, CO
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Hershey, Pennsylvania 17033
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Hershey, PA
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Los Angeles, California 90095
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from
Los Angeles, CA
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