Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch

Launched by THE HOSPITAL FOR SICK CHILDREN · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform surgery on newborns with a serious heart condition called Hypoplastic Left Heart Syndrome (HLHS), which includes a problem known as aortic arch hypoplasia. The goal is to create a special, custom-designed patch that can help reconstruct the aortic arch, allowing normal blood flow as the baby grows. By using advanced technology like 3D printing, doctors can create models of the heart and test different patch designs to find the best solution for each patient. This approach aims to make the surgery easier and more successful, ultimately improving the outcomes for these young patients.

To be eligible for this trial, babies aged 0 to 2 months who need a specific type of heart surgery called the Norwood procedure can participate, provided their parents give consent. The study will involve creating personalized patches based on detailed tests and imaging, and researchers will follow the babies as they grow to see how well the repairs are working. This innovative trial is not yet recruiting participants, but it offers hope for better surgical options for infants with complex heart conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newborns, 0-2 months of age
• • Requiring a Norwood procedure and aortic arch reconstruction
• • Consent provided
• Exclusion Criteria:
• • Consent not provided
• • Contraindications to contrast CT scans (allergy to contrast, kidney disease)
• • Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with the study, might confound the interpretation of the study results, or put the participant at risk