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

NCT06853054 | Not Yet Recruiting DMC

• 1 other identifier: 1000081239
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Congenital heart surgery; Aortic arch reconstruction; Surgical patch; Computer-aided design; 3D modeling and printing

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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).

  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

• Hemodynamic Stability: Blood pressure

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

  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

• Hemodynamic Stability: Heart Rate

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

  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

• Hemodynamic Stability: Oxygen Saturations (SpO2)

  Measured as a percentage (%) using a pulse oximeter.

  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 (10)

• Need for Re-intervention or Additional Surgeries (%)

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

• Incidence of Post-operative Complications (%)

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

• Growth Parameters at Follow-up: Weight

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

• Growth Parameters at Follow-up: Height

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

• Growth Parameters at Follow-up: Oxygen saturation in %

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

Study Arms (1)

Personalized Patch Template

EXPERIMENTAL

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.

Procedure: Personalized patch template

Interventions

Personalized patch template PROCEDURE

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

Personalized Patch Template

Eligibility Criteria

• Age: 0 Months - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns, 0-2 months of age
• Requiring a Norwood procedure and aortic arch reconstruction
• Consent provided

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 3X8, Canada

Location

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Cristina Salvo

CONTACT

416-813-7654; cristina.salvo@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiac Radiologist, Division of Cardiac Imaging, Department of Diagnostic Imaging

Model Details: Feasibility study to obtain preliminary data on the surgical outcomes (clinical hemodynamics, procedural times, reconstructed aortic arch configuration, geometry and size) of patients using traditional versus personalized patches.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: February 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)