Personalized Patch for HLHS

Overseen By Cristina Salvo

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Consent not provided, Allergy to contrast, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for babies with aortic arch narrowing or underdevelopment, such as those with Hypoplastic Left Heart Syndrome (HLHS). It aims to help these infants by using a personalized surgical patch designed from 3D printed models of their hearts.

Inclusion Criteria

I need surgery for my heart's structure and the aorta.

My baby is between 0 to 2 months old.

Consent provided

Exclusion Criteria

Consent not provided

Any condition or diagnosis that, in the opinion of the Principal Investigator or delegate, could 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

I cannot have CT scans with contrast due to allergies or kidney issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo a pre-operative contrast CT scan to design simulation models and identify the most ideal aortic arch configuration.

1 week

1 visit (in-person)

Surgery and Immediate Post-operative Care

Surgical reconstruction using a personalized patch template followed by immediate post-operative care including a research CT scan and 4D MRI scanning.

1 week

Daily assessments during the first week post-surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery with routine post-operative tests and imaging at 4-6 months.

6-12 months

Assessments at 1 month, 6 months, and 1 year follow-up

Treatment Details

Interventions

• Personalized Patch Template

Trial Overview The intervention being tested is the use of a graphically designed patient-specific patch for reconstructing the aortic arch in newborns. The study involves creating and testing various engineered patches on heart models before applying them in actual surgeries.

Participant Groups

Group I: Personalized Patch Template Experimental Treatment 1 Intervention

Using each participant's pre-operative imaging, the most ideal aortic arch configuration will be identified. This will be followed by simulation of mechanical effects on the adjacent structures by overlapping the designed aortic arch model on the participant's original images. Computer-aided design of the personalized patch template will then be completed and followed by 3D printing of the sterilizable, personalized patch template.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+