Comparing Two Surgical Techniques for Repairing Bicuspid Aortic Valve with Aortic Regurgitation in Adults

What this Trial Is About

Bicuspid aortic valve BAV disease can lead to significant aortic regurgitation AR in many patients, causing heart muscle problems and heart failure at a young age. This trial evaluates two different surgical techniques for repairing the aortic valve in BAV patients with AR, aiming to improve repair outcomes by comparing internal versus external annuloplasty methods. The study is a multicenter, prospective randomized controlled trial enrolling 100 patients with asymmetric BAV and AR but without root aneurysm. Participants will be randomly assigned to one of two groups the INTERNAL group receiving the HAART 200 internal annuloplasty ring designed for BAV, or the EXTERNAL group undergoing double external Dacron ring annuloplasty. Both groups will have aortic valve repair with specific sizing and surgical techniques, including cusp adjustments and, if needed, ascending aortic surgery. The INTERNAL ring is sized based on the non-fused cusp, while the EXTERNAL method stabilizes the basal ring and sinotubular junction with external rings or grafts. Participants will undergo 4D flow MRI scans before surgery, at hospital discharge, and one year after surgery to assess blood flow patterns and the degree of valve leakage. Researchers will measure reduction in flow eccentricity and regurgitation fraction as primary outcomes. Additional evaluations include valve function, heart muscle size and strain, adverse cardiac events, re-hospitalizations, device safety, and survival, with follow-up visits at 6 and 12 months. The study will last until mid-2027, involving detailed monitoring and imaging to compare the two repair techniques.

Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial