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

NCT06853054 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-01

No results posted yet for this study

Summary

Vascular Reconstruction is one of the most challenging areas of surgery, the surgeon has to create a completely watertight reconstruction without any narrowing or deformity that will restore normal flow characteristics, even at high pressures. Nowhere is this more challenging than in neonatal heart surgery where babies born with aortic arch narrowing or underdevelopment are one of the commonest life-threatening cardiovascular conditions.

Reconstruction not only has to recreate normal anatomy but also allow for subsequent growth and development.

Until now, surgical reconstruction depended on the surgeon's subjective assessment of the anatomy and a best estimate of patch shaping and design. New engineering techniques have enabled us to create 3D printed models of real hearts and then recreate the actual surgery on these models using a variety of engineered patches and different surgical techniques. These reconstructed models can now be placed in flow-testing rigs and undergo 4-dimensional flow imaging to provide high-fidelity velocity and shear force analysis that allow for precision design of the ideal geometry to give optimal flow.

This project will combine the skills of the largest team of neonatal heart surgeons in Canada, working with cardiac imaging experts, physicists and biomechanical engineers who are recognized as the world leaders in 3D printing technologies for congenital heart disease. Using a series of rigorous repeated tests and different designs we will define the ideal techniques and patch shapes and then translate this to real cases where a precision-shaped personalized patch can be created for each individual. Following up these babies as they grow with precision 3D scanning will show how these vessels are growing. Our mathematics-driven approach will make the surgery easier, shorter and more efficient. It will also provide more consistent surgical results among surgeons.

Conditions

  • Hypoplastic Left Heart Syndrome (HLHS)
  • Aortic Arch Hypoplasia

Interventions

PROCEDURE

Personalized patch template

The personalized, sterilizable patch template will be used as the surgeon's guide in fashioning the precise size and shape of the surgical patch.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-01-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06853054 on ClinicalTrials.gov