NCT Number: NCT06853054
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.
Trial opening soon.
Get Notified0 month–2 month
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 3X8, Canada
Christoph Haller
SUB_INVESTIGATOR
Christopher Macgowan
SUB_INVESTIGATOR
Cristina Salvo
CONTACT
416-813-7654 ext. 228847
David Barron
SUB_INVESTIGATOR
Israel Valverde
PRINCIPAL_INVESTIGATOR
Osami Honjo
SUB_INVESTIGATOR
Owais Khan
SUB_INVESTIGATOR
Rita Nobile
CONTACT
416-813-7500 ext. 203633
Shi-Joon Yoo
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The personalized, sterilizable patch template will be used as the surgeon's guide in fashioning the precise size and shape of the surgical patch.
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.
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).
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.
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.
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.
Time frame: During hospitalization, at 1 Month, 6 Months, and 1 Year Follow-up
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: Post-op Days 1-3, Post-op days 4-7, Post Discharge (1 month, 6 months, 1 year)
Percentage (%) of patients with complications (e.g., renal dysfunction, infection, bleeding, metabolic distress)
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Measurement of weight in kg
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Measurement of height (cm)
Time frame: At hospital discharge, at 1 Month, 6 Months, and 1 Year follow-up
Measurement of oxygen saturation SpO2 (%)
Time frame: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Aortic arch dimensions in mm (measured in different sections of the arch: ascending aorta, proximal, distal, isthmus).
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 in cm/s (measured using Doppler ultrasound or MRI 4D flow study).
Time frame: At pre-op, post-op day 1, and at follow-up: a 1 month, 6 months and 1 year post surgery
Qualitative assessment of ventricular function, the atrial septum, tricuspid regurgitation and neo-aortic regurgitation through echocardiography
Time frame: At 1 month, 6 months, and 1 year follow-up
Percentage (%) of patients requiring reintervention or experiencing complications
Time frame: At post-op Day 1 and at 1 month, 6 months and 1 year follow-up
Percentage (%) of patients with left pulmonary artery compression, left main bronchus compression, or aortic arch tortuosity as measured by CT or MRI scans.
Contact information is provided by the study sponsor or research team.
The Hospital for Sick Children
Other
A New Approach to Vascular Reconstruction Using Graphical 3D Printing and Flow Modelling to Create Personalized Precision Engineered Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07295730
Cardiovascular Abnormalities, Cardiovascular Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT02852031
Cardiovascular Abnormalities, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06768008
Aortic Coarctation, Aortic Stenosis
Beijing, China
View Trial DetailsNCT01856049
Cardiovascular Abnormalities, Cardiovascular Diseases
Rochester, Minnesota, United States
View Trial Details