Using 3D printed heart models for surgical planning in children with congenital heart disease
Official title: Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Run by Columbia University · NCT03891160 · Data updated 2026-11-12
This study tests if using 3D printed heart models can help doctors plan better surgeries for children with congenital heart disease who need a heart device.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Status | Recruiting |
| Started | January 22, 2020 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT03891160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children over 3 kilograms with congenital heart disease and heart failure who are eligible for mechanical circulatory support.
✕Probably not a fit
Patients who cannot tolerate cardiac MRI or CT scans will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research focuses on the benefits of utilizing a 3D printed heart model to enhance surgical planning for children diagnosed with congenital heart disease (CHD) and heart failure who require a ventricular assist device (VAD). The study aims to assess the correlation between the use of these models and improvements in patient outcomes, comparing results with those of patients who undergo VAD placement without the aid of a 3D model. By leveraging advanced imaging techniques, the study seeks to address the unique anatomical challenges presented by CHD patients, potentially leading to better surgical results.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and quality of life for children with congenital heart disease.
How similar studies have gone: Other studies have shown promising results with the use of advanced imaging techniques in surgical planning, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers. Exclusion Criteria: * Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.
Where it's running
-
Stanford University
Palo Alto, California, United States Recruiting -
University of Florida
Gainesville, Florida, United States Recruiting -
Children's Healthcare of Atlanta
Atlanta, Georgia, United States Recruiting -
Lurie Children's Hospital
Chicago, Illinois, United States Recruiting -
Columbia University
New York, New York, United States Recruiting -
Weill Cornell
New York, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Kanwal Farooqi, MD — Columbia University
- Study coordinator: Kanwal Farooqi, MD
- Email: kf2549@cumc.columbia.edu
- Phone: 212-305-8509
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.