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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Augsburg
NCT06869954 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 unde

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \< 170 degree) \[14\] 2. Severe aortic regurgitation (vena contracta (vc) \> 6mm and/or pressure half-time (PHT) \< 200 ms and/or effective regurgitant orifice area (EROA) \> 30 mm2 and/or regurgitant volume (RV) \> 60 ml/beat and/or left ventricular end-systolic diameter (LVESD) \> 50mm (or indexed LVESD \> 20mm/m2 BSA) and/or regurgitation fraction (RF) in cardiothoracic MRI \> 40%) (at least one parameter is required) \[15\] 3. Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery) 4. Willingness to participate and written informed consent 5. Age at surgery \> 18 years Exclusion Criteria: 1. Moderate/severe BAV stenosis (pmean \> 20mmHg) 2. Moderate/severe BAV cusp calcifications extending beyond the raphe region and/or necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon) 3. Concomitant aortic root aneurysm \> 45mm requiring simultaneous aortic root surgery \[16\] 4. Acute/subacute BAV endocarditis 5. Contraindication to MRI
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What it tests

  • Internal HAART 200 annuloplasty device
  • double external ring annuloplasty
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Where

4 sites
University Hospital Augsburg
Augsburg, Germany
University Heart and Vascular Center Frankfurt
Frankfurt am Main, Germany
Heart Center Leipzig
Leipzig, Germany
Medical Center Hamburg-Eppendorf
Hamburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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