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Bicuspid Valve Aortopathy Feasibility Study | Clinical Trials | Clareo Health

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COMPLETEDNCT01920815

Bicuspid Valve Aortopathy Feasibility 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 st...

Lead sponsor: Oregon Health and Science University•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Oregon Health and Science University

Collaborators

Emory University
University of Colorado, Denver
Baylor College of Medicine
University of California, Los Angeles
Penn State University

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.

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 19, 2018Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment500

Start dateJul 2013

Last updatedSep 19, 2018

Condition

Bicuspid Aortic Valve

Locations shown

University of California

Los Angeles, California

University of Colorado

Denver, Colorado

Emory University

Atlanta, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions