NCT04788082

Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.

Detailed description

3D imaging and rapid prototyping 3D printing technology have advanced to the point where it is feasible to marry the two to produce a patient-matched and accurate 3D model of congenital heart defects. The production of a 3D model of the heart may be particularly useful in anticipation of surgery such that the operator can plan and visualize the surgery prior to the surgical date with a physical heart he or she can manipulate in their hands. Preliminary studies demonstrate potential for clinical impact of 3D models on patient care and patient outcomes. 3D models have long been shown to enhance education and communication of anatomy. In 2008 Kim et al reviewed 3D printed models as an emerging technology in management of congenital heart disease, and also suggests that physical models may also help enhance patients and physicians' understanding of congenital heart disease. Our group has also published on the clinical and educational value of these 3D heart models. To date, no systematic trial identifying the value of 3D models on procedural planning has been published.

Conditions

• Double Outlet Right Ventricle
• Transposition of the Great Arteries
• Truncus Arteriosus
• Congenitally Corrected Transposition of the Great Arteries

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	3D Printed Heart Model	Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2021-03-09
• Last updated: 2021-03-09

Locations

3 sites across 1 country: United States