Bicuspid Valve Aortopathy Feasibility Study

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