3D Heart Models for Congenital Heart Disease

(IMMPACT Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen by Kanwal Farooqi, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Inability to tolerate CMR or CT

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies the use of 3D printed heart models to help plan surgeries for children with complex congenital heart disease and heart failure. The models aim to give doctors a better understanding of the patient's heart, potentially leading to safer and more effective surgeries. 3D printing technology is emerging as a potential new tool for planning medical interventions, particularly in congenital heart disease settings.

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 data supports the effectiveness of the treatment 3D heart models for congenital heart disease?

Research shows that 3D printed heart models help doctors better understand complex heart structures in congenital heart disease, improve surgical planning, and enhance communication with patients. These models have been shown to refine diagnostics and provide new anatomical information, leading to improved surgical outcomes. ^{1 2 3 4 5}

Is the use of 3D heart models safe for humans?

Research shows that 3D printed heart models are safe and can improve the planning and safety of complex heart surgeries in children, with no reported complications or deaths in the studies reviewed. ^{1 2 3 4 6}

How does the 3D heart model treatment differ from other treatments for congenital heart disease?

The 3D heart model treatment is unique because it uses personalized, three-dimensional printed models of a patient's heart to improve understanding of complex heart defects, assist in surgical planning, and enhance communication between doctors and patients. Unlike traditional imaging, these models provide a tangible, accurate representation of the heart's anatomy, which can be particularly beneficial for planning complex procedures and educating both medical professionals and patients. ^{1 2 3 7 8}

Research Team

Kanwal Farooqi, MD

Principal Investigator

Columbia University

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• 3D model of heart (Procedure)

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.

Participant Groups

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+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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]

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]

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-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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and accuracy of printed models of complex cardiac defects in small infants from cardiac computed tomography. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Three-Dimensional Printed Models in Congenital Heart Disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional printed models in congenital heart disease. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Three-Dimensional Virtual and Printed Prototypes in Complex Congenital and Pediatric Cardiac Surgery-A Multidisciplinary Team-Learning Experience. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

[Application of Three-Dimensional Printed Models in Congenital Heart Surgery: Surgeon's Perspective]. [2022]

6. Hungary 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]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Utility of three-dimensional models in resident education on simple and complex intracardiac congenital heart defects. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Current and future applications of 3D printing in congenital cardiology and cardiac surgery. [2022]