Status:
COMPLETED
Bicuspid Valve Aortopathy Feasibility Study
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Emory University
University of Colorado, Denver
Conditions:
Bicuspid Aortic Valve
Eligibility:
All Genders
18-90 years
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Bicuspid aortic valve
- Aortic measurement of 35 - 49 mm on prior imaging study
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 4 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01920815
Start Date
July 1 2013
End Date
October 4 2017
Last Update
September 19 2018
Active Locations (6)
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1
University of California
Los Angeles, California, United States
2
University of Colorado
Denver, Colorado, United States
3
Emory University
Atlanta, Georgia, United States
4
Oregon Health and Science University
Portland, Oregon, United States, 97239