Tetralogy of Fallot (TOF)NCT07295730
3D Modalities for Medical Student Education of Congenital Heart Disease
A study testing 3D-printed heart models and augmented reality in people with Tetralogy of Fallot (TOF) and Hypoplastic Left Heart Syndrome (HLHS), run by Case Western Reserve University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetralogy of Fallot (TOF), Hypoplastic Left Heart Syndrome (HLHS)
- What is being tested?
- 3D-printed heart models and augmented reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to 9 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First year medical student
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106
About this study
Official title: Use of 3D-printed Models and Augmented Reality in Medical Student Education of Congenital Heart Disease: Randomized Controlled Trial
The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are:
- Does using 3D-printed heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
- Does using augmented reality heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
- How can these modalities best be integrated into standard medical school curricula?
Read more
Participants will:
- Take a pre-test consisting of questions regarding anatomy and physiology of the normal heart as well as two congenital heart diseases.
- Be randomized into 3 groups that receive a teaching session using either slide-based lecture, 3D-printed models, or augmented reality.
- Take a post-test of the same questions from the pre-test.
- Take a delayed post-test of the same questions with additional subjective questions about their experience with their assigned modality.
- Being tested
- 3D-printed heart models and augmented reality
- Medical subject headings
- Tetralogy of Fallot, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed heart models and augmented realityOther
Participants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets.
| Study group | Role | What they receive |
|---|---|---|
| Slide-based lecture | Other | Participants in this group received teaching using a slide-based lecture Receives: Other: 3D-printed heart models and augmented reality |
| 3D-printed Model | Active comparator | This group received teaching using 3D-printed models Receives: Other: 3D-printed heart models and augmented reality |
| Augmented Reality | Active comparator | This group received teaching using augmented reality headsets Receives: Other: 3D-printed heart models and augmented reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pre and Post-test Scores
Participants completed a 16-item, multiple choice questionnaire about the anatomy and physiology of the normal heart and two complex congenital heart defects. The questionnaire is broken down into 4 questions on basic cardiology and 6 questions each pertaining specifically to tetralogy of Fallot and hypoplastic left heart syndrome. The questionnaire is delivered pre-intervention, immediately post-intervention, and again at 3-weeks post intervention. Correct answers are scored as true (1) and incorrect answers scored as false (0) with a score range of 0-16 with higher scores indicating better retention and understanding of the curriculum.
Measured: Enrollment Pre-Intervention, Baseline Post-Intervention, and 3 Weeks Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Nov 2025
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of Fallot (TOF)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arpit Agarwal, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295730
- Sponsor's protocol ID
- STUDY20240627
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 3D-printed Models and Augmented Reality in Medical Student Education of Congenital Heart Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07295730
- Acronym / sponsor ID
- STUDY20240627
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 22 Dec 2025 (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.
The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are:
- Does using 3D-printed heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
- Does using augmented reality heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
- How can these modalities best be integrated into standard medical school curricula?
Participants will:
- Take a pre-test consisting of questions regarding anatomy and physiology of the normal heart as well as two congenital heart diseases.
- Be randomized into 3 groups that receive a teaching session using either slide-based lecture, 3D-printed models, or augmented reality.
- Take a post-test of the same questions from the pre-test.
- Take a delayed post-test of the same questions with additional subjective questions about their experience with their assigned modality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slide-based lecture | Other | Other: 3D-printed heart models and augmented realityParticipants in this group received teaching using a slide-based lecture |
| 3D-printed Model | Active comparator | Other: 3D-printed heart models and augmented realityThis group received teaching using 3D-printed models |
| Augmented Reality | Active comparator | Other: 3D-printed heart models and augmented realityThis group received teaching using augmented reality headsets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First year medical student
Key exclusion criteria (1 listed)
- -
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 models and augmented realityParticipants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets. | Other | 3D-printed Model, Augmented Reality, Slide-based lecture |
Primary outcome
Changes in Pre and Post-test Scores
Time frame: Enrollment Pre-Intervention, Baseline Post-Intervention, and 3 Weeks Post-Intervention
Participants completed a 16-item, multiple choice questionnaire about the anatomy and physiology of the normal heart and two complex congenital heart defects. The questionnaire is broken down into 4 questions on basic cardiology and 6 questions each pertaining specifically to tetralogy of Fallot and hypoplastic left heart syndrome. The questionnaire is delivered pre-intervention, immediately post-intervention, and again at 3-weeks post intervention. Correct answers are scored as true (1) and incorrect answers scored as false (0) with a score range of 0-16 with higher scores indicating better retention and understanding of the curriculum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Related trials for Tetralogy of Fallot (TOF)
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
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.
Arpit Agarwal, MD principal investigator
University Hospitals Cleveland Medical Center
1 site 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 models and augmented reality in people with Tetralogy of Fallot (TOF) and Hypoplastic Left Heart Syndrome (HLHS), run by Case Western Reserve University at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pre and Post-test Scores (time frame: Enrollment Pre-Intervention, Baseline Post-Intervention, and 3 Weeks Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.