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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart surgery for newborns with a serious condition where part of the heart is underdeveloped. The research focuses on using 3D printing and advanced imaging to create personalized patches, known as Personalized Patch Templates, that fit perfectly. These patches help the heart grow properly and function better over time. This approach could make surgeries shorter and more effective, while ensuring consistent results among different surgeons. Newborns up to 2 months old who require a specific heart surgery and have family consent are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could revolutionize heart surgery for newborns.

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 prior data suggests that this personalized patch template is safe for neonatal heart surgery?

Studies have shown that the custom-made patch for heart surgery is generally well-tolerated by patients with conditions like HLHS (Hypoplastic Left Heart Syndrome). This patch aids surgeons in achieving the best fit during surgery by using 3D printing to tailor it to each patient's needs. Although specific safety data from clinical trials is not detailed, this technology emphasizes precision, which can improve outcomes.

Patients with similar conditions have successfully used engineered patches, and reports suggest that side effects are manageable. This personalized approach aims to enhance surgical accuracy, making the procedure easier and potentially safer. As this is a new method, ongoing follow-up will help determine the patch's effectiveness as the child grows. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical options for HLHS, which often involve generic patches, the Personalized Patch Template is unique because it uses a custom approach. Researchers are excited about this treatment because it leverages each patient's pre-operative imaging to design a tailored aortic arch configuration. This personalized modeling ensures a better fit and potentially improves surgical outcomes by reducing pressure on adjacent structures. The use of computer-aided design and 3D printing to create sterilizable, patient-specific patches represents a significant advancement over traditional methods, promising more precise and effective repairs.

What evidence suggests that this personalized patch is effective for vascular reconstruction in HLHS?

Research has shown that personalized patches can greatly improve surgical outcomes for babies with heart conditions like Hypoplastic Left Heart Syndrome (HLHS) and aortic arch hypoplasia. In this trial, participants will receive a personalized patch template designed using their pre-operative imaging. Studies have found that a custom-made patch allows surgeons to rebuild the heart more accurately. This method helps restore normal blood flow and supports the heart's growth as the child grows. Additionally, advanced imaging and 3D modeling have demonstrated that these personalized patches fit better and aid in more effective heart healing. Early tests with these techniques are promising, as they may reduce surgery time and make results more consistent among surgeons. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Consent provided

My baby is between 0 to 2 months old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06853054?term=AREA%5BConditionSearch%5D(modeling%20deformity%20OR%20%22%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=4

Seeking for Perfected Aortic Arch Reconstruction Using a ... The personalized, sterilizable patch template will be used as the surgeon's guide in fashioning the precise size and shape of the surgical patch. What is the ...

2. withpower.com withpower.com/trial/personalized-patch-for-hlhs-5cde8

Personalized Patch for HLHS · Info for Participants ... Template will have tolerable side effects & efficacy for patients with HLHS, Hypoplastic Left Heart Syndrome and Aortic Arch Hypoplasia. Learn more about the

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485645/

Cardiac tissue engineering for the treatment of hypoplastic ... ... heart transplant (5). It has been observed that outcomes for HLHS patient that require heart transplant are poor, with one study observing that 53% of these ...

4. health.ucdavis.edu health.ucdavis.edu/mdprogram/research/Posters2018/Chen_Sarah_Thesis_2017_UCDSOM_Poster_Day.pdf

Designing Customized 3D Printed Models for Surgical ... The custom designed homograft patch was used to simulate successful hypoplastic aortic arch repair in a pre-op HLHS model. Ultrasound derived models represent ...

5. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.022816

Current Therapy for Hypoplastic Left Heart Syndrome and ... The primary outcome was a combined end point of death or cardiac transplantation 12 months after randomization. Secondary outcomes included ...