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

Launched by UNIVERSITY HOSPITAL AUGSBURG · Mar 5, 2025

Keywords

ClinConnect Summary

The CONTOUR trial is a research study aiming to improve the treatment of patients with a specific heart condition called bicuspid aortic valve (BAV) disease, which can lead to severe aortic regurgitation (AR). In this trial, researchers will compare two different techniques for repairing the aortic valve to see which one works better. The study will involve 100 patients with BAV and severe AR from four medical centers in Germany. Participants will be randomly assigned to receive one of two types of valve repair: one using an internal device designed to create a more symmetrical shape for the valve, and the other using a traditional external method. The goal is to determine which method leads to better outcomes, such as reduced abnormal blood flow and less regurgitation one year after surgery.

To be eligible for this trial, patients must be over 18 years old and have a specific type of BAV with severe AR. They should not have certain other heart conditions or complications that could affect the surgery. Participants will undergo MRI scans before and after the surgery to help assess how well the valve is functioning. The findings from this trial could lead to better treatment options for patients with BAV disease and influence future guidelines for managing this condition.

Gender

ALL

Eligibility 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