Back to resultsClinical Impact of Rapid Prototyping 3D Models for Surgical Management
Primary Purpose
Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D Printed Heart Model
Sponsored by
About this trial
This is an interventional treatment trial for Double Outlet Right Ventricle focused on measuring 3D Printing, Rapid prototpying
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Phoenix Children's Hospital
- Children's National Medical Center
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
3D Model
Arm Description
Standard of care (not involving 3D printing)
3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.
Outcomes
Primary Outcome Measures
Time under cardiopulmonary bypass
Secondary Outcome Measures
Mortality
Intraoperative death or intraprocedural death
Unexpected Cardiac arrest during or following procedure
Bleeding, Requiring reoperation
Sternum left open, Unplanned
Unplanned cardiac reoperation
Unplanned non-cardiac reoperation
Mechanical circulatory support (IABP, VAD, ECMO, or CPS)
Answer "yes"/"no"
Arrhythmia necessitating pacemaker, Permanent pacemaker
Renal failure (discharge dialysis)
acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge
Renal failure (temporary dialysis)
acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge
Renal failure (hemofiltration)
acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge
Sepsis
Sepsis (following Society of Thoracic Surgery definition)
Seizure
Seizure (following Society of Thoracic Surgery definition)
Stroke
Stroke (following Society of Thoracic Surgery definition)
Vocal cord dysfunction (possible recurrent laryngeal nerve injury)
Other operative/procedural complication
Other operative/procedural complication (following Society of Thoracic Surgery definition)
Technology Assessment
A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models
Full Information
NCT ID
NCT04788082
First Posted
August 29, 2017
Last Updated
March 4, 2021
Sponsor
Children's National Research Institute
Collaborators
Phoenix Children's Hospital, Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT04788082
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollments
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
Phoenix Children's Hospital, Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries
Keywords
3D Printing, Rapid prototpying
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care (not involving 3D printing)
Arm Title
3D Model
Arm Type
Experimental
Arm Description
3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D Printed Heart Model
Other Intervention Name(s)
Rapid Prototyped Heart Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time under cardiopulmonary bypass
Time Frame
peri-operative
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Up to 30 days post-operative
Title
Intraoperative death or intraprocedural death
Time Frame
peri-operative
Title
Unexpected Cardiac arrest during or following procedure
Time Frame
From surgical date through 30 days post-operative
Title
Bleeding, Requiring reoperation
Time Frame
From surgical date through 30 days post-operative
Title
Sternum left open, Unplanned
Time Frame
From surgical date through 30 days post-operative
Title
Unplanned cardiac reoperation
Time Frame
From surgical date through 30 days post-operative
Title
Unplanned non-cardiac reoperation
Time Frame
From surgical date through 30 days post-operative
Title
Mechanical circulatory support (IABP, VAD, ECMO, or CPS)
Description
Answer "yes"/"no"
Time Frame
From surgical date through 30 days post-operative
Title
Arrhythmia necessitating pacemaker, Permanent pacemaker
Time Frame
From surgical date through 30 days post-operative
Title
Renal failure (discharge dialysis)
Description
acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge
Time Frame
From surgical date through 30 days post-operative
Title
Renal failure (temporary dialysis)
Description
acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge
Time Frame
From surgical date through 30 days post-operative
Title
Renal failure (hemofiltration)
Description
acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge
Time Frame
From surgical date through 30 days post-operative
Title
Sepsis
Description
Sepsis (following Society of Thoracic Surgery definition)
Time Frame
From surgical date through 30 days post-operative
Title
Seizure
Description
Seizure (following Society of Thoracic Surgery definition)
Time Frame
From surgical date through 30 days post-operative
Title
Stroke
Description
Stroke (following Society of Thoracic Surgery definition)
Time Frame
From surgical date through 30 days post-operative
Title
Vocal cord dysfunction (possible recurrent laryngeal nerve injury)
Time Frame
From surgical date through 30 days post-operative
Title
Other operative/procedural complication
Description
Other operative/procedural complication (following Society of Thoracic Surgery definition)
Time Frame
From surgical date through 30 days post-operative
Title
Technology Assessment
Description
A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models
Time Frame
Preop, Periop, and up to 30 days a
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Olivieri, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Pophal, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoav Dori, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Cardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.
Results Reference
background
PubMed Identifier
24958045
Citation
Costello JP, Olivieri LJ, Krieger A, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Utilizing Three-Dimensional Printing Technology to Assess the Feasibility of High-Fidelity Synthetic Ventricular Septal Defect Models for Simulation in Medical Education. World J Pediatr Congenit Heart Surg. 2014 Jul;5(3):421-6. doi: 10.1177/2150135114528721.
Results Reference
background
PubMed Identifier
25385353
Citation
Costello JP, Olivieri LJ, Su L, Krieger A, Alfares F, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Incorporating three-dimensional printing into a simulation-based congenital heart disease and critical care training curriculum for resident physicians. Congenit Heart Dis. 2015 Mar-Apr;10(2):185-90. doi: 10.1111/chd.12238. Epub 2014 Nov 11.
Results Reference
background
PubMed Identifier
22436025
Citation
Cui X, Boland T, D'Lima DD, Lotz MK. Thermal inkjet printing in tissue engineering and regenerative medicine. Recent Pat Drug Deliv Formul. 2012 Aug;6(2):149-55. doi: 10.2174/187221112800672949.
Results Reference
background
Citation
Davis FD, Bagozzi RP, Warshaw PR. User Acceptance of Computer Technology: A Comparison of Two Theoretical Models. Management Science 35(8): 982-1003, 1989.
Results Reference
background
PubMed Identifier
11973204
Citation
Dexter F, Macario A. Changing allocations of operating room time from a system based on historical utilization to one where the aim is to schedule as many surgical cases as possible. Anesth Analg. 2002 May;94(5):1272-9, table of contents. doi: 10.1097/00000539-200205000-00042.
Results Reference
background
Citation
Does RJMM, Vermaat TMB, Verver JPS, Bisgaard S, Van Den Heuvel J. Reducing Start Time Delays in Operating Rooms. Journal of Quality Technology 41(1): 95-109, 2009.
Results Reference
background
Citation
Ejaz F, Ryan J, Henriksen M, Stomski L, Feith M, Osborn M, Pophal S, Richardson R, Frakes D. Color-coded patient-specific physical models of congenital heart disease. Rapid Prototyping Journal 20(4): 336-343, 2014.
Results Reference
background
PubMed Identifier
25060372
Citation
Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Ailawadi G, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson TB Jr, Horvath KA, Moquete EG, Parides MK, Bagiella E, O'Gara PT, Blackstone EH; Cardiothoracic Surgical Trials Network (CTSN). Management practices and major infections after cardiac surgery. J Am Coll Cardiol. 2014 Jul 29;64(4):372-81. doi: 10.1016/j.jacc.2014.04.052.
Results Reference
background
PubMed Identifier
20470679
Citation
Hu A, Wilson T, Ladak H, Haase P, Doyle P, Fung K. Evaluation of a three-dimensional educational computer model of the larynx: voicing a new direction. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):315-22.
Results Reference
background
PubMed Identifier
18458180
Citation
Kim MS, Hansgen AR, Wink O, Quaife RA, Carroll JD. Rapid prototyping: a new tool in understanding and treating structural heart disease. Circulation. 2008 May 6;117(18):2388-94. doi: 10.1161/CIRCULATIONAHA.107.740977.
Results Reference
background
Citation
King WR, He J. A meta-analysis of the technology acceptance model. Information & Management 43(6): 740-755, 2006.
Results Reference
background
PubMed Identifier
22421029
Citation
Kutty S, Graney BA, Khoo NS, Li L, Polak A, Gribben P, Hammel JM, Smallhorn JF, Danford DA. Serial assessment of right ventricular volume and function in surgically palliated hypoplastic left heart syndrome using real-time transthoracic three-dimensional echocardiography. J Am Soc Echocardiogr. 2012 Jun;25(6):682-9. doi: 10.1016/j.echo.2012.02.008. Epub 2012 Mar 14.
Results Reference
background
PubMed Identifier
22183020
Citation
Lang RM, Badano LP, Tsang W, Adams DH, Agricola E, Buck T, Faletra FF, Franke A, Hung J, de Isla LP, Kamp O, Kasprzak JD, Lancellotti P, Marwick TH, McCulloch ML, Monaghan MJ, Nihoyannopoulos P, Pandian NG, Pellikka PA, Pepi M, Roberson DA, Shernan SK, Shirali GS, Sugeng L, Ten Cate FJ, Vannan MA, Zamorano JL, Zoghbi WA; American Society of Echocardiography; European Association of Echocardiography. EAE/ASE recommendations for image acquisition and display using three-dimensional echocardiography. J Am Soc Echocardiogr. 2012 Jan;25(1):3-46. doi: 10.1016/j.echo.2011.11.010. No abstract available.
Results Reference
background
Citation
Mavroudis C, Backer C, Idriss RF. Pediatric Cardiac Surgery, 4 edition. Hoboken, NJ, Wiley-Blackwell, 2012.
Results Reference
background
Citation
Moreno Cegarra JL, Cegarra Navarro JG, Córdoba Pachón JR. Applying the technology acceptance model to a Spanish City Hall. International Journal of Information Management 34(4): 437-445, 2014.
Results Reference
background
PubMed Identifier
18573436
Citation
Mottl-Link S, Hubler M, Kuhne T, Rietdorf U, Krueger JJ, Schnackenburg B, De Simone R, Berger F, Juraszek A, Meinzer HP, Karck M, Hetzer R, Wolf I. Physical models aiding in complex congenital heart surgery. Ann Thorac Surg. 2008 Jul;86(1):273-7. doi: 10.1016/j.athoracsur.2007.06.001.
Results Reference
background
PubMed Identifier
497341
Citation
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
Results Reference
background
PubMed Identifier
24447757
Citation
Olivieri L, Krieger A, Chen MY, Kim P, Kanter JP. 3D heart model guides complex stent angioplasty of pulmonary venous baffle obstruction in a Mustard repair of D-TGA. Int J Cardiol. 2014 Mar 15;172(2):e297-8. doi: 10.1016/j.ijcard.2013.12.192. Epub 2014 Jan 8. No abstract available.
Results Reference
background
PubMed Identifier
25457761
Citation
Ryan JR, Moe TG, Richardson R, Frakes DH, Nigro JJ, Pophal S. A novel approach to neonatal management of tetralogy of Fallot, with pulmonary atresia, and multiple aortopulmonary collaterals. JACC Cardiovasc Imaging. 2015 Jan;8(1):103-104. doi: 10.1016/j.jcmg.2014.04.030. Epub 2014 Nov 12. No abstract available.
Results Reference
background
PubMed Identifier
17462413
Citation
Sodian R, Weber S, Markert M, Rassoulian D, Kaczmarek I, Lueth TC, Reichart B, Daebritz S. Stereolithographic models for surgical planning in congenital heart surgery. Ann Thorac Surg. 2007 May;83(5):1854-7. doi: 10.1016/j.athoracsur.2006.12.004.
Results Reference
background
PubMed Identifier
19131439
Citation
Weidenbach M, Razek V, Wild F, Khambadkone S, Berlage T, Janousek J, Marek J. Simulation of congenital heart defects: a novel way of training in echocardiography. Heart. 2009 Apr;95(8):636-41. doi: 10.1136/hrt.2008.156919. Epub 2009 Jan 8.
Results Reference
background
PubMed Identifier
14666011
Citation
Wypij D, Newburger JW, Rappaport LA, duPlessis AJ, Jonas RA, Wernovsky G, Lin M, Bellinger DC. The effect of duration of deep hypothermic circulatory arrest in infant heart surgery on late neurodevelopment: the Boston Circulatory Arrest Trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1397-403. doi: 10.1016/s0022-5223(03)00940-1.
Results Reference
background
PubMed Identifier
17717378
Citation
Yarbrough AK, Smith TB. Technology acceptance among physicians: a new take on TAM. Med Care Res Rev. 2007 Dec;64(6):650-72. doi: 10.1177/1077558707305942. Epub 2007 Aug 23.
Results Reference
background
Links:
URL
http://childrensnational.org/
Description
Children's National Medical Center
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Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
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