Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Withdrawn before enrolling · Not applicable

Conditions studied: Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries

In brief

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.

Key facts

Study ID

NCT04788082

Run by

Children's National Research Institute

People needed

0

Starts

2017-05-01

Expected to finish

2021-06-01

Last updated by the study team

2021-03-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Complex defects involving atrioventricular valve anomalies
• complete or transitional atrioventricular canal
• double inlet left ventricle
• tricuspid atresia
• mitral atresia
• Defects with valve dysfunction requiring an extensive valvuloplasty
• Patients with a contraindication to MRI scanning will be excluded unless they are referred for a cardiac CT per clinical standard of practice. These contraindications include patients with the following devices:
• Central nervous system aneurysm clips
• Implanted neural stimulator
• Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
• Cochlear implant
• Ocular foreign body (e.g. metal shavings)
• Implanted Insulin pump
• Metal shrapnel or bullet.
• Any contraindications to receiving IV gadolinium contrast, determined clinically
• Subjects where MRI or CT images are acquired more than six months prior to the scheduled surgical date
• Subjects where date of scan to date of surgery is less than 10 calendar days
• Subjects where MRI or CT reconstruction is limited due to poor image acquisition as solely determined by the Image Reconstruction Center.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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