NCT06869954

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Augsburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient 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. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study. Methods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up. Discussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.

Conditions

• Bicuspid Aortic Valve (BAV)
• Aortic Regurgitation Disease

Interventions

Type	Name	Description
DEVICE	Internal HAART 200 annuloplasty device	For the INTERNAL group, the HAART 200 internal annuloplasty ring (CorCym, London, UK), specifically designed for BAV morphology, will be used for all patients. Intraoperative sizing for the internal ring is based on the geometric orientation and size of the non-fused cusp. A standard ball sizer is used for the measurement of the non-fused cusp to assess commissural orientation and surface area of the non-fused cusp. Sizing typically results in values of 23mm or 25mm, with other sizes being very rare. Both commissural posts of the internal annuloplasty ring are fixed using two subcommissural sutures \[10\]. A modified technique for placement of transannular looping sutures will be used to secure the internal ring in the subannular position, as recently published \[21\]. Cusp maneuvers (i.e., shaving, thinning of the raphe, central plication sutures) will be performed to achieve an effective height of 8-10 mm. When indicated (i.e., for ascending aortic diameter \> 45mm or aiming to achieve th
DEVICE	double external ring annuloplasty	For the EXTERNAL group, all study patients will undergo double external Dacron ring annuloplasty by simultaneous stabilization of the basal virtual ring and the STJ \[22\]. The surgical technique of double external annuloplasty, detailed by the Lansac group \[22\], involves aortic annulus sizing with a Hegar dilator to select the sizes of the external subannular annuloplasty ring and STJ ring (same size). After deep dissection of the aortic root, 6-7 2-0 pledgeted U sutures are placed circumferentially at the level of the virtual basal ring for external subannular ring implantation. Cusp maneuvers are performed similar to those in the INTERNAL group. STJ stabilization is achieved using an external STJ ring or ascending aortic replacement with a vascular tube graft (e.g., in cases with a high offspring of the right coronary artery). Treatment of the tubular ascending aorta is identical to the INTERNAL group.

Timeline

• Start date: 2025-05-21
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-03-11
• Last updated: 2025-10-07

Locations

4 sites across 1 country: Germany