Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of the CONTOUR Trial.

OBJECTIVES

Aortic valve repair is an evolving and still underused strategy in young bicuspid aortic valve (BAV) patients with aortic regurgitation (AR). The lack of standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus.

METHODS

The CONTOUR trial is a multicentre RCT designed to compare 2 aortic valve annuloplasty concepts in 100 consecutive BAV patients. BAV AR patients with an asymmetric configuration and without aortopathy will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (INTERNAL group) or double external annuloplasty using Extra Aortic ring (EXTERNAL group). 4 D flow magnetic resonance imaging (MRI) will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of haemodynamic profiles (ie, flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary end-points will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up.

RESULTS

The CONTOUR trial is the first RCT designed to compare 2 different annuloplasty techniques in their effectivity to create a completely symmetric post-repair BAV geometry and to achieve superior aortic valve repair outcomes.

CONCLUSIONS

The study findings are expected to significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.

TRIAL REGISTRATION: NCT06869954.