Status:
WITHDRAWN
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Phoenix Children's Hospital
Children's Hospital of Philadelphia
Conditions:
Double Outlet Right Ventricle
Transposition of the Great Arteries
Eligibility:
All Genders
Phase:
NA
Brief 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,...
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04788082
Start Date
May 1 2017
End Date
June 1 2021
Last Update
March 9 2021
Active Locations (3)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104