Clinical trial NCT04788082: Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
Official title: Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Double Outlet Right Ventricle
Transposition of the Great Arteries
Truncus Arteriosus
Congenitally Corrected Transposition of the Great Arteries
Keywords: 3D Printing
Rapid prototpying
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Phoenix Children's Hospital
name: Children's Hospital of Philadelphia
First posted: 2021-03-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time under cardiopulmonary bypass
timeFrame: peri-operative
Secondary outcomes:
measure: Mortality
timeFrame: Up to 30 days post-operative
measure: Intraoperative death or intraprocedural death
timeFrame: peri-operative
measure: Unexpected Cardiac arrest during or following procedure
timeFrame: From surgical date through 30 days post-operative
measure: Bleeding, Requiring reoperation
timeFrame: From surgical date through 30 days post-operative
measure: Sternum left open, Unplanned
timeFrame: From surgical date through 30 days post-operative
measure: Unplanned cardiac reoperation
timeFrame: From surgical date through 30 days post-operative
measure: Unplanned non-cardiac reoperation
timeFrame: From surgical date through 30 days post-operative
measure: Mechanical circulatory support (IABP, VAD, ECMO, or CPS)
timeFrame: From surgical date through 30 days post-operative
measure: Arrhythmia necessitating pacemaker, Permanent pacemaker
timeFrame: From surgical date through 30 days post-operative
measure: Renal failure (discharge dialysis)
timeFrame: From surgical date through 30 days post-operative
measure: Renal failure (temporary dialysis)
timeFrame: From surgical date through 30 days post-operative
measure: Renal failure (hemofiltration)
timeFrame: From surgical date through 30 days post-operative
measure: Sepsis
timeFrame: From surgical date through 30 days post-operative
measure: Seizure
timeFrame: From surgical date through 30 days post-operative
measure: Stroke
timeFrame: From surgical date through 30 days post-operative
measure: Vocal cord dysfunction (possible recurrent laryngeal nerve injury)
timeFrame: From surgical date through 30 days post-operative
measure: Other operative/procedural complication
timeFrame: From surgical date through 30 days post-operative
measure: Technology Assessment
timeFrame: Preop, Periop, and up to 30 days a
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's National Research Institute
name: Laura Olivieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phoenix Children's Hospital
name: Stephen Pophal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Yoav Dori, MD
role: PRINCIPAL_INVESTIGATOR
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