Hypoplastic Left Heart Syndrome (HLHS)NCT06853054
Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch
A study testing Personalized patch template in people with Hypoplastic Left Heart Syndrome (HLHS) and Aortic Arch Hypoplasia, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 months
- Conditions the study is for
- Hypoplastic Left Heart Syndrome (HLHS), Aortic Arch Hypoplasia
- What is being tested?
- Personalized patch template
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns, 0-2 months of age
- Requiring a Norwood procedure and aortic arch reconstruction
- Consent provided
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G 3X8
Cristina Salvo, 416-813-7654 ext. 228847, cristina.salvo@sickkids.ca
Rita Nobile, 416-813-7500 ext. 203633, rita.nobile@sickkids.ca
About this study
Official title: A New Approach to Vascular Reconstruction Using Graphical 3D Printing and Flow Modelling to Create Personalized Precision Engineered Surgery
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.
Read more
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.
Read the detailed description
Aortic arch reconstruction complications can be prevented or minimalized by personalizing the surgical technique and patch through mathematical computer modeling and 3D printing.
This is a feasibility study on the use of graphical 3D printing and flow modelling in the creation of personalized patch templates for the Norwood procedure and aortic arch reconstruction.
Patients undergoing the Norwood procedure as part of standard of care will be approached for consent. Patients who consent to the study will undergo a pre-operative contrast CT scan to design simulation models and to identify the most ideal aortic arch configuration. 3D printing of the sterilizable template will be done after computer-aided design of bespoke surgical patches and will be based on pre-operative imaging and simulation. The sterilizable patch template will be used by the surgeon as a guide to fashioning the precise size and shape of the patch.
A research CT scan will be done post-operatively, prior to patient discharge. The post-op CT scan will be used to create a 3D printed model of the reconstructed aortic arch, This 3D printed model will then undergo 4D MRI scanning as part of the analysis.
Patients will be monitored and followed closely post-surgery. They will be assessed by routine post-operative tests including standard of care imaging at 4-6 months after surgery.
Clinical outcome assessment at 6-12 months after surgery will be measured.
This data will be compared to surgical outcomes of a historical cohort of patients who had traditional patches.
- Being tested
- Personalized patch template
- Keywords
- Congenital heart surgery, Aortic arch reconstruction, Surgical patch, Computer-aided design, 3D modeling and printing
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized patch templateProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Personalized patch template |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (%)
Patient status (Need for re-exploration, reoperation, or catheter-based interventions) measured by the percentage (%) of patients requiring additional surgical or catheter-based interventions.
Measured: During hospitalization, at 1 Month, 6 Months, and 1 Year Follow-up
Incidence of Post-operative Complications (%)
Percentage (%) of patients with complications (e.g., renal dysfunction, infection, bleeding, metabolic distress)
Measured: Post-op Days 1-3, Post-op days 4-7, Post Discharge (1 month, 6 months, 1 year)
Growth Parameters at Follow-up: Weight
Measurement of weight in kg
Measured: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Growth Parameters at Follow-up: Height
Measurement of height (cm)
Measured: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Growth Parameters at Follow-up: Oxygen saturation in %
Measurement of oxygen saturation SpO2 (%)
Measured: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Aortic Arch Dimensions (mm)
Aortic arch dimensions in mm (measured in different sections of the arch: ascending aorta, proximal, distal, isthmus).
Measured: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Flow velocity
Flow velocity in cm/s (measured using Doppler ultrasound or MRI 4D flow study).
Measured: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Cardiac Function (Ventricular Function and Valve Regurgitation) and Heart Structure (Atrial Septum Integrity)
Qualitative assessment of ventricular function, the atrial septum, tricuspid regurgitation and neo-aortic regurgitation through echocardiography
Measured: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Long-term Reintervention or Complications
Percentage (%) of patients requiring reintervention or experiencing complications
Measured: At 1 month, 6 months, and 1 year follow-up
Incidence of Structural Issues (Pulmonary or Bronchial Compression) (%)
Percentage (%) of patients with left pulmonary artery compression, left main bronchus compression, or aortic arch tortuosity as measured by CT or MRI scans.
Measured: At post-op Day 1 and at 1 month, 6 months and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Sep 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart Syndrome (HLHS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Shi-Joon Yoo, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853054
- Sponsor's protocol ID
- 1000081239
- Status last verified
- Jul 2025
- First submitted
- 7 Nov 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Vascular Reconstruction Using Graphical 3D Printing and Flow Modelling to Create Personalized Precision Engineered Surgery
- ClinicalTrials.gov ID
- NCT06853054
- Acronym / sponsor ID
- 1000081239
- Keywords
- Congenital heart surgery, Aortic arch reconstruction, Surgical patch, Computer-aided design, 3D modeling and printing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aortic arch reconstruction complications can be prevented or minimalized by personalizing the surgical technique and patch through mathematical computer modeling and 3D printing.
This is a feasibility study on the use of graphical 3D printing and flow modelling in the creation of personalized patch templates for the Norwood procedure and aortic arch reconstruction.
Patients undergoing the Norwood procedure as part of standard of care will be approached for consent. Patients who consent to the study will undergo a pre-operative contrast CT scan to design simulation models and to identify the most ideal aortic arch configuration. 3D printing of the sterilizable template will be done after computer-aided design of bespoke surgical patches and will be based on pre-operative imaging and simulation. The sterilizable patch template will be used by the surgeon as a guide to fashioning the precise size and shape of the patch.
A research CT scan will be done post-operatively, prior to patient discharge. The post-op CT scan will be used to create a 3D printed model of the reconstructed aortic arch, This 3D printed model will then undergo 4D MRI scanning as part of the analysis.
Patients will be monitored and followed closely post-surgery. They will be assessed by routine post-operative tests including standard of care imaging at 4-6 months after surgery.
Clinical outcome assessment at 6-12 months after surgery will be measured.
This data will be compared to surgical outcomes of a historical cohort of patients who had traditional patches.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized Patch Template | Experimental | Procedure: Personalized patch templateUsing 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 may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns, 0-2 months of age
- Requiring a Norwood procedure and aortic arch reconstruction
- Consent provided
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized patch templateThe personalized, sterilizable patch template will be used as the surgeon's guide in fashioning the precise size and shape of the surgical patch. | Procedure or surgery | Personalized Patch Template |
Primary outcome
Survival Rate (%): patient status (Alive/Dead)
Time frame: In hospital, at 30 days and at 1 year follow-up
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.
Hemodynamic Stability: Inotrope Requirement (daily score)
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
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).
Hemodynamic Stability: Blood pressure
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
Measured in mmHg using a standard non-invasive sphygmomanometer or an arterial catheter for continuous measurement in the ICU.
Hemodynamic Stability: Heart Rate
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
Measured in beats per minute (bpm) using ECG or pulse oximeter.
Hemodynamic Stability: Oxygen Saturations (SpO2)
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
Measured as a percentage (%) using a pulse oximeter.
10 secondary outcomes
Need for Re-intervention or Additional Surgeries (%)
Time frame: During hospitalization, at 1 Month, 6 Months, and 1 Year Follow-up
Incidence of Post-operative Complications (%)
Time frame: Post-op Days 1-3, Post-op days 4-7, Post Discharge (1 month, 6 months, 1 year)
Growth Parameters at Follow-up: Weight
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Growth Parameters at Follow-up: Height
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Growth Parameters at Follow-up: Oxygen saturation in %
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Aortic Arch Dimensions (mm)
Time frame: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Flow velocity
Time frame: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Cardiac Function (Ventricular Function and Valve Regurgitation) and Heart Structure (Atrial Septum Integrity)
Time frame: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Long-term Reintervention or Complications
Time frame: At 1 month, 6 months, and 1 year follow-up
Incidence of Structural Issues (Pulmonary or Bronchial Compression) (%)
Time frame: At post-op Day 1 and at 1 month, 6 months and 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized patch template in people with Hypoplastic Left Heart Syndrome (HLHS) and Aortic Arch Hypoplasia, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Salvo (416-813-7654 ext. 228847, cristina.salvo@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate (%): patient status (Alive/Dead) (time frame: In hospital, at 30 days and at 1 year follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.