Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

March 4, 2021 updated by: Laura Olivieri, Children's National Research Institute

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

    1. double outlet right ventricle (DORV),
    2. transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),
    3. truncus arteriosus with ventricular septal defect (TA/VSD)
    4. 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 Criteria:

  • Complex defects involving atrioventricular valve anomalies

    1. complete or transitional atrioventricular canal
    2. double inlet left ventricle
    3. tricuspid atresia
    4. 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:

    1. Central nervous system aneurysm clips
    2. Implanted neural stimulator
    3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
    4. Cochlear implant
    5. Ocular foreign body (e.g. metal shavings)
    6. Implanted Insulin pump
    7. Metal shrapnel or bullet.
    8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Rapid Prototyped Heart Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time under cardiopulmonary bypass
Time Frame: peri-operative
peri-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 30 days post-operative
Up to 30 days post-operative
Intraoperative death or intraprocedural death
Time Frame: peri-operative
peri-operative
Unexpected Cardiac arrest during or following procedure
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Bleeding, Requiring reoperation
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Sternum left open, Unplanned
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Unplanned cardiac reoperation
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Unplanned non-cardiac reoperation
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Mechanical circulatory support (IABP, VAD, ECMO, or CPS)
Time Frame: From surgical date through 30 days post-operative
Answer "yes"/"no"
From surgical date through 30 days post-operative
Arrhythmia necessitating pacemaker, Permanent pacemaker
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Renal failure (discharge dialysis)
Time Frame: From surgical date through 30 days post-operative
acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge
From surgical date through 30 days post-operative
Renal failure (temporary dialysis)
Time Frame: From surgical date through 30 days post-operative
acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge
From surgical date through 30 days post-operative
Renal failure (hemofiltration)
Time Frame: From surgical date through 30 days post-operative
acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge
From surgical date through 30 days post-operative
Sepsis
Time Frame: From surgical date through 30 days post-operative
Sepsis (following Society of Thoracic Surgery definition)
From surgical date through 30 days post-operative
Seizure
Time Frame: From surgical date through 30 days post-operative
Seizure (following Society of Thoracic Surgery definition)
From surgical date through 30 days post-operative
Stroke
Time Frame: From surgical date through 30 days post-operative
Stroke (following Society of Thoracic Surgery definition)
From surgical date through 30 days post-operative
Vocal cord dysfunction (possible recurrent laryngeal nerve injury)
Time Frame: From surgical date through 30 days post-operative
From surgical date through 30 days post-operative
Other operative/procedural complication
Time Frame: From surgical date through 30 days post-operative
Other operative/procedural complication (following Society of Thoracic Surgery definition)
From surgical date through 30 days post-operative
Technology Assessment
Time Frame: Preop, Periop, and up to 30 days a
A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models
Preop, Periop, and up to 30 days a

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Collaborators

Children's Hospital of Philadelphia
Phoenix Children's Hospital

Investigators

  • Principal Investigator: Laura Olivieri, MD, Children's National Research Institute
  • Principal Investigator: Stephen Pophal, MD, Phoenix Children's Hospital
  • Principal Investigator: Yoav Dori, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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