Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of the CONTOUR Trial.
Evaldas Girdauskas, Sina Stock, Daniel Hofbauer...
https://pubmed.ncbi.nlm.nih.gov/41124604Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06869954
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial
Led by University Hospital Augsburg · Updated on 2025-10-07
100
Participants Needed
4
Research Sites
N/A
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
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.
CONDITIONS
Brief Title
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Presence of fused bicuspid aortic valve (BAV) phenotype with asymmetric configuration (commissural orientation less than 170 degrees)
- Severe aortic regurgitation by at least one parameter: vena contracta > 6mm, pressure half-time < 200 ms, effective regurgitant orifice area > 30 mm2, regurgitant volume > 60 ml/beat, left ventricular end-systolic diameter > 50mm (or indexed LVESD > 20mm/m2 body surface area), or regurgitation fraction > 40% on MRI
- Planned isolated aortic valve surgery or with concomitant procedures including coronary artery bypass grafting, mitral/tricuspid valve surgery, or ascending aortic surgery
- Willingness to participate and 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 calcifications of the valve cusps extending beyond the raphe or requiring patch implantation
- Concomitant aortic root aneurysm larger than 45 mm needing root surgery
- Acute or subacute bicuspid aortic valve endocarditis
- Contraindication to MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo bicuspid aortic valve repair surgery using one of two surgical techniques involving internal or external annuloplasty devices and associated procedures.
1 surgical visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge
Participants receive immediate post-operative care following their valve repair surgery to monitor recovery and manage early complications.
Several in-hospital visits (in-person)
Post-operative Follow-up
Duration - 12 months
Participants attend scheduled follow-up visits to assess valve function, cardiac health, and device safety at multiple time points after surgery.
Visits at baseline (post-procedure), 6 months, and 12 months (in-person)
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
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Research Team
E
Evaldas Girdauskas, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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