Double Outlet Right VentricleNCT04788082
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
A study testing 3D Printed Heart Model in people with Double Outlet Right Ventricle and Transposition of the Great Arteries, run by Children's National Research Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus
- What is being tested?
- 3D Printed Heart Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2017to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries
- Being tested
- 3D Printed Heart Model
- Keywords
- 3D Printing, Rapid prototpying
- Medical subject headings
- Double Outlet Right Ventricle, Transposition of Great Vessels, Truncus Arteriosus, Persistent, Congenitally Corrected Transposition of the Great Arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Heart ModelDiagnostic test
Also called Rapid Prototyped 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care (not involving 3D printing) |
| 3D Model | Experimental | 3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning. Receives: Diagnostic Test: 3D Printed Heart Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time under cardiopulmonary bypass
Measured: peri-operative
Secondary outcomes (18)
Mortality
Measured: Up to 30 days post-operative
Intraoperative death or intraprocedural death
Measured: peri-operative
Unexpected Cardiac arrest during or following procedure
Measured: From surgical date through 30 days post-operative
Bleeding, Requiring reoperation
Measured: From surgical date through 30 days post-operative
Sternum left open, Unplanned
Measured: From surgical date through 30 days post-operative
Unplanned cardiac reoperation
Measured: From surgical date through 30 days post-operative
Unplanned non-cardiac reoperation
Measured: From surgical date through 30 days post-operative
Mechanical circulatory support (IABP, VAD, ECMO, or CPS)
Answer "yes"/"no"
Measured: From surgical date through 30 days post-operative
Arrhythmia necessitating pacemaker, Permanent pacemaker
Measured: From surgical date through 30 days post-operative
Renal failure (discharge dialysis)
acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge
Measured: From surgical date through 30 days post-operative
Renal failure (temporary dialysis)
acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge
Measured: From surgical date through 30 days post-operative
Renal failure (hemofiltration)
acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge
Measured: From surgical date through 30 days post-operative
Sepsis
Sepsis (following Society of Thoracic Surgery definition)
Measured: From surgical date through 30 days post-operative
Seizure
Seizure (following Society of Thoracic Surgery definition)
Measured: From surgical date through 30 days post-operative
Stroke
Stroke (following Society of Thoracic Surgery definition)
Measured: From surgical date through 30 days post-operative
Vocal cord dysfunction (possible recurrent laryngeal nerve injury)
Measured: From surgical date through 30 days post-operative
Other operative/procedural complication
Other operative/procedural complication (following Society of Thoracic Surgery definition)
Measured: From surgical date through 30 days post-operative
Technology Assessment
A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models
Measured: Preop, Periop, and up to 30 days a
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 May 2017
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: No enrollments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Double Outlet Right VentricleStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Children's Hospital, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Laura Olivieri, Children's National Research Institute
- Investigators
- Laura Olivieri, MD, Principal investigator, Children's National Research InstituteStephen Pophal, MD, Principal investigator, Phoenix Children's HospitalYoav Dori, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788082
- Sponsor's protocol ID
- 15-090
- Status last verified
- Mar 2021
- First submitted
- 29 Aug 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.
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.
PubMed 24958045Costello 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.
PubMed 25385353Cui 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.
PubMed 22436025Davis FD, Bagozzi RP, Warshaw PR. User Acceptance of Computer Technology: A Comparison of Two Theoretical Models. Management Science 35(8): 982-1003, 1989.
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.
PubMed 11973204Does 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.
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.
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.
PubMed 25060372Hu 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.
PubMed 20470679Kim 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.
PubMed 18458180King WR, He J. A meta-analysis of the technology acceptance model. Information & Management 43(6): 740-755, 2006.
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.
PubMed 22421029Lang 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.
PubMed 22183020Mavroudis C, Backer C, Idriss RF. Pediatric Cardiac Surgery, 4 edition. Hoboken, NJ, Wiley-Blackwell, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management
- ClinicalTrials.gov ID
- NCT04788082
- Acronym / sponsor ID
- 15-090
- Conditions
- Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries
- Keywords
- 3D Printing, Rapid prototpying
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Phoenix Children's Hospital, Children's Hospital of Philadelphia
- Study start
- 1 May 2017 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care (not involving 3D printing) |
| 3D Model | Experimental | Diagnostic Test: 3D Printed Heart Model3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:
- Patient who will undergo preoperative cardiac MR or cardiac CT imaging
- 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.
Key exclusion criteria (18 listed)
- Complex defects involving atrioventricular valve anomalies
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed Heart ModelAlso: Rapid Prototyped Heart ModelPrior 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. | Diagnostic test | 3D Model |
Primary outcome
Time under cardiopulmonary bypass
Time frame: peri-operative
18 secondary outcomes
Mortality
Time frame: Up to 30 days post-operative
Intraoperative death or intraprocedural death
Time frame: peri-operative
Unexpected Cardiac arrest during or following procedure
Time frame: From surgical date through 30 days post-operative
Bleeding, Requiring reoperation
Time frame: From surgical date through 30 days post-operative
Sternum left open, Unplanned
Time frame: From surgical date through 30 days post-operative
Unplanned cardiac reoperation
Time frame: From surgical date through 30 days post-operative
Unplanned non-cardiac reoperation
Time frame: 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
Arrhythmia necessitating pacemaker, Permanent pacemaker
Time frame: From surgical date through 30 days post-operative
Renal failure (discharge dialysis)
Time frame: From surgical date through 30 days post-operative
Renal failure (temporary dialysis)
Time frame: From surgical date through 30 days post-operative
Renal failure (hemofiltration)
Time frame: From surgical date through 30 days post-operative
Sepsis
Time frame: From surgical date through 30 days post-operative
Seizure
Time frame: From surgical date through 30 days post-operative
Stroke
Time frame: 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
Other operative/procedural complication
Time frame: From surgical date through 30 days post-operative
Technology Assessment
Time frame: Preop, Periop, and up to 30 days a
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- BackgroundCardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.
- Background: PubMed 24958045Costello 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.
- Background: PubMed 25385353Costello 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.
- Background: PubMed 22436025Cui 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.
- BackgroundDavis FD, Bagozzi RP, Warshaw PR. User Acceptance of Computer Technology: A Comparison of Two Theoretical Models. Management Science 35(8): 982-1003, 1989.
- Background: PubMed 11973204Dexter 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.
- BackgroundDoes 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.
- BackgroundEjaz 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.
- Background: PubMed 25060372Gelijns 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.
- Background: PubMed 20470679Hu 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.
- Background: PubMed 18458180Kim 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.
- BackgroundKing WR, He J. A meta-analysis of the technology acceptance model. Information & Management 43(6): 740-755, 2006.
- Phoenix Children's Hospital's 3D Print LabLink provided by the sponsor.
- Children's National Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Olivieri, MD principal investigator
Children's National Research Institute
Stephen Pophal, MD principal investigator
Phoenix Children's Hospital
Yoav Dori, MD principal investigator
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Heart Model in people with Double Outlet Right Ventricle and Transposition of the Great Arteries, run by Children's National Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time under cardiopulmonary bypass (time frame: peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788082, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.