3D Heart Models for Congenital Heart Disease

(IMMPACT Trial)

Recruiting at 23 trial locations

Overseen By Kanwal Farooqi, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Inability to tolerate CMR or CT

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if 3D printed heart models can improve surgical planning for children with congenital heart disease (CHD) who require a ventricular assist device (VAD) to support heart function. Researchers will compare the outcomes of surgeries planned with 3D models to those without them to assess whether the models enhance surgical clarity and success. Children with CHD and heart failure who weigh more than 3 kilograms and are candidates for mechanical heart support may be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance surgical planning and outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3D heart model is safe for surgical planning in children with congenital heart disease?

Research has shown that 3D printed heart models are safe because they are non-invasive and used for planning surgeries, not for treatment. Nothing is placed directly into the body. Studies have found that these models accurately replicate the heart's structure, aiding doctors in planning surgeries more effectively. This can result in safer and more precise procedures for patients with congenital heart disease, a condition present at birth that affects the heart's structure. No reports indicate problems directly caused by using these models, as they primarily assist doctors in visualizing and planning surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D heart models for congenital heart disease because they offer a new level of precision in surgical planning. Unlike traditional 2D imaging, these 3D models provide a tangible, detailed view of the heart's structure, which can help surgeons better understand the specific sites for cannula and ventricular assist device (VAD) placement. This enhanced clarity could lead to more accurate surgeries and potentially better outcomes for patients.

What evidence suggests that a 3D heart model is effective for surgical planning in congenital heart disease?

Studies have shown that 3D printed heart models can greatly improve understanding of complex heart structures. In this trial, Group A will use 3D printed models for pre-VAD planning, potentially aiding doctors in better surgical planning by clearly indicating device placement. Research indicates that these models enhance surgical planning and execution. In education, 3D models have also helped medical students and doctors learn more about heart anatomy. These findings suggest that 3D printed models could lead to better outcomes for children needing heart surgery. Meanwhile, Group B will serve as the control group and will not use a 3D model. ^{6 7 8 9 10}

Who Is on the Research Team?

Kanwal Farooqi, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for children over 3 kilograms with Congenital Heart Disease (CHD) and heart failure who are candidates for mechanical circulatory support. It's not suitable for those unable to tolerate a cardiac MRI or CT scan.

Inclusion Criteria

I weigh more than 3 kilograms and am a candidate for a mechanical circulatory support device due to heart failure.

Exclusion Criteria

I can undergo CMR or cardiac CT scans without issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Planning

3D printed heart models are used for surgical planning in Group A, while Group B proceeds without the model

4 weeks

1 visit (in-person) for imaging and model review

Surgical Intervention

Ventricular assist device (VAD) placement surgery is performed

1 week

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after VAD placement, including assessment of cardiopulmonary bypass time

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 3D model of heart

Trial Overview The study is examining the benefits of using a personalized 3D printed model of the heart to plan surgeries involving ventricular assist device placement in kids with CHD, compared to planning without it.

How Is the Trial Designed?

Group I: Group A - 3D models Experimental Treatment 1 Intervention

Group A will receive 3-D printed models will be used for pre-VAD planning. For patients in Group A, the surgeon will complete a questionnaire 1) after reviewing 2D imaging data and 2) after reviewing a patient specific 3D model. The investigators primary outcome measure will be an improvement in the clarity of cannula and VAD site demonstration. The investigators hypothesize that the 3D models will more clearly demonstrate the sites of cannula and VAD placement as compared to 2D imaging.

Group II: Group B - Control Active Control 1 Intervention

Group B will be the controls and will not receive a 3D model.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Three-dimensional (3D) printing has advanced significantly in congenital heart disease (CHD), allowing for highly accurate models that can replicate complex cardiac anatomy with errors of less than 1 mm, which can aid in surgical planning.

Despite the potential benefits, challenges such as high costs, lengthy production times (18-24 hours), and the need for standardization in the modeling process currently limit the widespread use of 3D printed models in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional printed models in congenital heart disease. Cantinotti, M., Valverde, I., Kutty, S.[2022]

3D printing technology is rapidly advancing in congenital cardiology and cardiac surgery, allowing for the creation of patient-specific models that help clinicians visualize complex heart anatomies.

Despite its promising applications in surgical planning, training, and patient communication, there is currently limited scientific evidence supporting the clinical benefits of 3D models, with most evaluations being qualitative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future applications of 3D printing in congenital cardiology and cardiac surgery. Milano, EG., Capelli, C., Wray, J., et al.[2022]

Patient-specific 3D printed heart models significantly enhance the understanding of complex congenital heart disease (CHD) by providing personalized visualizations that improve spatial comprehension of cardiac structures.

These models not only aid in preoperative planning and simulation of procedures but also serve as valuable educational tools and improve communication between doctors and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Three-Dimensional Printed Models in Congenital Heart Disease. Sun, Z., Lau, I., Wong, YH., et al.[2022]

Using 3D printed models during educational sessions significantly improved the understanding of tetralogy of Fallot (ToF) among pediatric residents, highlighting the effectiveness of these models for complex congenital heart defects.

While the 3D models did not enhance understanding of ventricular septal defects (VSD) compared to traditional methods, they provided valuable spatial context for more complicated conditions like ToF, suggesting their utility in teaching complex anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of three-dimensional models in resident education on simple and complex intracardiac congenital heart defects. White, SC., Sedler, J., Jones, TW., et al.[2022]

3D-printed models of the heart and great vessels were created for 12 pediatric patients undergoing complex cardiac surgeries, demonstrating excellent accuracy and refining diagnostics in 8 out of 12 cases, which led to improved surgical planning.

The use of these models contributed to successful outcomes in complex procedures without any morbidity or mortality, highlighting their potential to enhance the safety of congenital cardiac surgeries, although financial coverage for their use remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-dimensional virtual and printed models improve preoperative planning and promote patient-safety in complex congenital and pediatric cardiac surgery]. Király, L.[2019]

3-D printed models created from cardiac CT scans in young children with complex congenital heart diseases are feasible and can be accurately generated, as demonstrated in a study involving 14 children with a mean age of 5.5 months.

The accuracy of these models is high, with mean measurement differences between the CT images and the 3-D models being non-clinically significant, indicating that the printed models reliably reflect the actual anatomical structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and accuracy of printed models of complex cardiac defects in small infants from cardiac computed tomography. Hadeed, K., Guitarte, A., Briot, J., et al.[2021]

3D-printed models of the heart and great vessels were created for 15 patients undergoing complex congenital cardiac surgery, showing high accuracy with a deviation of only 1 mm from actual intraoperative structures.

These models significantly improved surgical planning, leading to refined diagnostics in 13 out of 15 cases and contributing to safer surgical approaches without any operative morbidity or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Dimensional Virtual and Printed Prototypes in Complex Congenital and Pediatric Cardiac Surgery-A Multidisciplinary Team-Learning Experience. Kiraly, L., Shah, NC., Abdullah, O., et al.[2022]

Three-dimensional (3D) printed models of the heart provide a clearer understanding of complex congenital heart disease structures, which can be challenging to visualize using traditional imaging methods like CT and MRI.

These models are being increasingly utilized for educational purposes, preoperative simulations, and improving decision-making in surgical planning, potentially enhancing surgical techniques and training for cardiac surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of Three-Dimensional Printed Models in Congenital Heart Surgery: Surgeon's Perspective]. Kim, H., Choo, KS., Sung, SC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949787/

The impact of 3D printed vs. 3D virtual congenital heart ... Participants in both 3D model groups exhibited significant improvements in their knowledge of cardiac anatomy after viewing the 3D models ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S277281292400109X

Pilot Study on Integrating 3D-Printed Models Into ... This study aimed to assess the feasibility and effectiveness of implementing 3-dimensional (3D)-printed heart models in the education of medical students.

3. nature.com nature.com/articles/s41390-025-03999-x

Evaluating 3D-printed models for congenital heart disease 3D-printed models were well-received and will be integrated into routine practice to enhance education on CHD procedures and optimize physician-parent ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03891160

Study Details | NCT03891160 | Implementing Models for ... The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6119737/

Three‐dimensional printing in congenital heart disease 3D printed models improve understanding of complex cardiac anatomy, assist precise surgical planning and execution of all surgeries. Kiraly et al37 2016 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6517984/

Personalized Three-Dimensional Printed Models in ... The first step to generate a 3D printed heart model is to undergo a series of image post-processing and segmentation of volumetric data, which are commonly ...

7. mdpi.com mdpi.com/2227-9067/10/2/319

Patient-Specific 3D-Printed Models in Pediatric Congenital ... This review provides an overview of 3D-printed models in pediatric CHD, with a focus on educational value for medical students or graduates.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1054880724000863

High-resolution three-dimensional atlas of congenital heart ... A 3D interactive atlas of congenital heart defects was developed and published. The resolution of the data was 41 um, faithfully representing delicate ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9610217/

3D Printed Models in Cardiovascular Disease 3D printed heart and vascular models replicate normal anatomy and pathology with high accuracy and demonstrate superior advantages over the standard image ...

10. ucsf.edu ucsf.edu/news/2023/04/425186/how-3d-printer-heart-technology-changed-teens-life

How 3D Printer Heart Technology Changed a Teen's Life 3D printer heart technology changed a teen's life. Surgeons can now pinpoint heart disease thanks to recent advances in modeling.