Condition: Bicuspid Aortic Valve (BAV) · Aortic Regurgitation Disease · Sponsor: University Hospital Augsburg
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 f…
This description comes directly from the study's public registry record.
Evaldas Girdauskas, Prof. · +49 821 4002671 · evaldas.girdauskas@uk-augsburg.de
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06869954