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

Status: Withdrawn
Location: See all (3) locations...
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Healthy Volunteers: No

• Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:

• double outlet right ventricle (DORV),

• transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),

• truncus arteriosus with ventricular septal defect (TA/VSD)

• congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS).

• Patient who will undergo preoperative cardiac MR or cardiac CT imaging

• a. Images will be validated by the IRC prior to inclusion

• Written informed consent (and assent when applicable) and HIPAA authorization obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

United States
Phoenix Children's Hospital
Washington, D.c.
Children's National Medical Center
Children's Hospital of Philadelphia
Time Frame
Start Date: May 1, 2017
Completion Date: June 2021
No Intervention: Control
Standard of care (not involving 3D printing)
Experimental: 3D Model
3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.
Leads: Children's National Research Institute
Collaborators: Children's Hospital of Philadelphia, Phoenix Children's Hospital

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