Actively Recruiting
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
Led by University Hospital Augsburg · Updated on 2025-10-07
100
Participants Needed
4
Research Sites
105 weeks
Total Duration
On this page
Sponsors
U
University Hospital Augsburg
Lead Sponsor
U
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of fused bicuspid aortic valve with asymmetric configuration (commissural orientation less than 170 degrees)
- Severe aortic regurgitation defined by at least one of the following: vena contracta over 6mm, pressure half-time under 200 ms, effective regurgitant orifice area over 30 mm2, regurgitant volume over 60 ml per beat, left ventricular end-systolic diameter over 50mm (or indexed over 20mm/m2 body surface area), or regurgitation fraction over 40% by MRI
- Scheduled for isolated aortic valve surgery or with additional procedures such as coronary bypass or mitral/tricuspid valve surgery or ascending aortic surgery
- Willing and able to provide written informed consent
- Age over 18 years at time of surgery
You will not qualify if you...
- Moderate or severe bicuspid aortic valve stenosis (mean pressure gradient over 20 mmHg)
- Moderate or severe valve cusp calcifications extending beyond the raphe or requiring patch implantation as decided by the surgeon
- Aortic root aneurysm larger than 45mm needing root surgery
- Acute or subacute bicuspid aortic valve infection (endocarditis)
- Contraindication to magnetic resonance imaging (MRI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Hospital Augsburg
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
2
University Heart and Vascular Center Frankfurt
Frankfurt am Main, Hesse, Germany, 60598
Not Yet Recruiting
3
Heart Center Leipzig
Leipzig, Saxony, Germany, 04289
Not Yet Recruiting
4
Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
Research Team
E
Evaldas Girdauskas, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here