Comparing two ways to stabilize the bicuspid aortic valve during repair
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial
This trial will test whether an internal HAART 200 annuloplasty device or a double external ring annuloplasty gives better repair results for adults with asymmetric bicuspid aortic valves and severe aortic regurgitation who need valve surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Augsburg Academic / other |
| Locations | 4 sites (Augsburg, Bavaria and 3 other locations) |
| Trial ID | NCT06869954 on ClinicalTrials.gov |
What this trial studies
CONTOUR is a multicenter, randomized trial in Germany enrolling 100 adults with fused, asymmetric bicuspid aortic valves and severe aortic regurgitation to compare two annuloplasty concepts. Eligible patients without a concomitant root aneurysm are randomized 1:1 to receive either an internal HAART 200 annuloplasty device or a double external ring annuloplasty at the time of aortic valve repair. The trial will collect surgical, echocardiographic, and clinical outcomes to compare annular stabilization, recurrence of regurgitation, and need for reoperation. Participating centers include University Hospital Augsburg, Universitätsklinikum Hamburg-Eppendorf, University Heart and Vascular Center Frankfurt, and Heart Center Leipzig.
Who should consider this trial
Good fit: Adults over 18 with a fused, asymmetric bicuspid aortic valve and severe aortic regurgitation who are scheduled for isolated aortic valve surgery (or with allowed concomitant procedures) and can give informed consent are ideal candidates.
Not a fit: Patients with moderate/severe stenosis, extensive cusp calcification that prevents repair, root aneurysm, or other anatomical features that make repair infeasible are unlikely to benefit from the randomized comparison.
Why it matters
Potential benefit: If successful, the better annuloplasty method could make bicuspid aortic valve repairs last longer and reduce the need for repeat operations.
How similar studies have performed: Device-specific and observational series have shown promise for both internal and external annuloplasty approaches, but randomized comparisons like this are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augsburg, Bavaria and 3 other locations
- University Hospital Augsburg — Augsburg, Bavaria, Germany (Recruiting)
- University Heart and Vascular Center Frankfurt — Frankfurt am Main, Hesse, Germany (Not_yet_recruiting)
- Heart Center Leipzig — Leipzig, Saxony, Germany (Not_yet_recruiting)
- Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Evaldas Girdauskas, Prof.
- Email: evaldas.girdauskas@uk-augsburg.de
- Phone: +49 821 4002671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.