Bicuspid Valve Aortopathy Feasibility Study
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 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