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New treatment option for Bicuspid Aortic Valve (BAV)
Official title Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
ClinicalTrials.gov ID: NCT06869954
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \< 170 degree) [14]
- Severe aortic regurgitation (vena contracta (vc) \> 6mm and/or pressure half-time (PHT) \ 30 mm2 and/or regurgitant volume (RV) \> 60 ml/beat and/or...
- Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery)
- Willingness to participate and written informed consent
- Age at surgery \> 18 years
You likely can't join if
- Moderate/severe BAV stenosis (pmean \> 20mmHg)
- Moderate/severe BAV cusp calcifications extending beyond the raphe region and/or necessitating patch implantation (deemed irreparable based on...
- Concomitant aortic root aneurysm \> 45mm requiring simultaneous aortic root surgery [16]
- Acute/subacute BAV endocarditis
- Contraindication to MRI
The study team makes the final eligibility decision.
Where it's taking place
- Augsburg, Bavaria, Germany
- Frankfurt am Main, Hesse, Germany
- Leipzig, Saxony, Germany
- Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augsburg, Bavaria, Germany; Frankfurt am Main, Hesse, Germany; Leipzig, Saxony, Germany; Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.