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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorThe Hospital for Sick Children

About 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 does not accept healthy volunteers

Qualifiers

Newborns, 0-2 months of age

Requiring a Norwood procedure and aortic arch reconstruction

Consent provided

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Personalized patch template

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Personalized Patch TemplateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival Rate (%): patient status (Alive/Dead)

Survival will be recorded based on patient status at the time of discharge (in-hospital), 30 days post-surgery, and at 1-year follow-up. The unit of measure will be the percentage of patients who remain alive at each of these time points.

Time frame
In hospital, at 30 days and at 1 year follow-up
2

Hemodynamic Stability: Inotrope Requirement (daily score)

A scale measuring the need for inotropic support, based on the number and type of inotropic medications required. Inotropic support will be quantified on a daily score (ranging from 0 to a maximum score depending on inotrope usage).

Time frame
Post-op Day 1: Initial assessment within 24 hours of surgery, Post-op Days 2-7: Daily assessments during the first week post-surgery, 1 month, 6 months, 1 year follow up: Evaluation of ongoing hemodynamic stability
3

Hemodynamic Stability: Blood pressure

Measured in mmHg using a standard non-invasive sphygmomanometer or an arterial catheter for continuous measurement in the ICU.

Time frame
Post-op Day 1: Initial assessment within 24 hours of surgery, Post-op Days 2-7: Daily assessments during the first week post-surgery, 1 month, 6 months, 1 year follow up: Evaluation of ongoing hemodynamic stability
4

Hemodynamic Stability: Heart Rate

Measured in beats per minute (bpm) using ECG or pulse oximeter.

Time frame
Post-op Day 1: Initial assessment within 24 hours of surgery, Post-op Days 2-7: Daily assessments during the first week post-surgery, 1 month, 6 months, 1 year follow up: Evaluation of ongoing hemodynamic stability

Secondary outcomes

1

Need for Re-intervention or Additional Surgeries (%)

Patient status (Need for re-exploration, reoperation, or catheter-based interventions) measured by the percentage (%) of patients requiring additional surgical or catheter-based interventions.

Time frame
During hospitalization, at 1 Month, 6 Months, and 1 Year Follow-up
2

Incidence of Post-operative Complications (%)

Percentage (%) of patients with complications (e.g., renal dysfunction, infection, bleeding, metabolic distress)

Time frame
Post-op Days 1-3, Post-op days 4-7, Post Discharge (1 month, 6 months, 1 year)
3

Growth Parameters at Follow-up: Weight

Measurement of weight in kg

Time frame
At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
4

Growth Parameters at Follow-up: Height

Measurement of height (cm)

Time frame
At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: