Using 3D printed heart models for surgical planning in children with congenital heart disease
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 5 sites (Gainesville, Florida and 4 other locations) |
| Trial ID | NCT03891160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children over 3 kilograms with congenital heart disease and heart failure who are eligible for mechanical circulatory support.
Not a fit: Patients who cannot tolerate cardiac MRI or CT scans will not benefit from this study.
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 performed: Other studies have shown promising results with the use of advanced imaging techniques in surgical planning, suggesting potential success for this novel approach.
Eligibility criteria
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 this trial is running
Gainesville, Florida and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.