Satisfaction, PersonalNCT06758141
3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training
A study testing 3D printed educational model and Slide-based presentation in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The objective of this study is to develop advanced cardiac models using 3D printing technology for teaching complex cardiology procedures such as (1) transseptal puncture, (2) cardiac ablation, and (3) ultrasound scanning and drainage of cardiac tamponade. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- 3D printed educational model and Slide-based presentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2025to 8 Jan 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
- Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital
Who cannot join
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Using 3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training to Enhance Medical Education: A Randomized Controlled Educational Trial
The objective of this study is to develop advanced cardiac models using 3D printing technology for teaching complex cardiology procedures such as (1) transseptal puncture, (2) cardiac ablation, and (3) ultrasound scanning and drainage of cardiac tamponade. By implementing this study, the investigators aim to transform the teaching methods for cardiology students at our hospital.
Read the detailed description
Background： The standard methodology for education in medicine, particularly in cardiology, still follows the apprenticeship model, where trainees observe, gradually take over, and practice under supervision until they can independently perform procedures. The traditional pedagogical strategy for complex medical procedures, like cardiac catheterization, emphasizes the "see one, do one, teach one" doctrine. Studies have revealed the superior efficacy of 3D printing in medical education, particularly in enhancing learning skills and knowledge among medical students. The demand for 3D printed models in medical education is increasing continuously.
Study Design：
This study is a single-center, pilot, prospective, randomized controlled educational trial.
Methods：
The trial will be conducted in the Department of Cardiovascular Medicine at Fu Jen Catholic University Hospital. The investigators plan to enroll 50 participants, who will be randomly assigned to either the 3D model training group (n=25) or the conventional curriculum group (n=25) in a 1:1 ratio. All participants will undergo pre- and post-training assessments, including a knowledge test (structured written questionnaire), an attitude assessment (semi-structured satisfaction questionnaire), and a skills evaluation (direct observation of procedural skills, DOPS).
Effect：
The investigators anticipate the development of a set of advanced 3D cardiac models for teaching cardiology procedures. It is expected that combining classroom learning with the viewing and interactive practice of 3D printed models will significantly improve the learning outcomes of the trainees.
Key words：
Clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade.
- Conditions
- Satisfaction, Personal
- Being tested
- 3D printed educational model, Slide-based presentation
- Keywords
- clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade
- Medical subject headings
- Personal Satisfaction, Cardiac Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed educational modelOther
3D Printed Advanced Cardiac Model
Slide-based presentationOther
Slide-based presentation
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed presention group | Experimental | Received a routine presentation plus 3D printing model Receives: Other: 3D printed educational model |
| Slide-based presention group | Active comparator | Received a routine presentation Receives: Other: Slide-based presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination score of pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome
Measured: pre-intervention
Examination score of post-intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start6 Jan 2025
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758141
- Sponsor's protocol ID
- FJUH113381
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training to Enhance Medical Education: A Randomized Controlled Educational Trial
- ClinicalTrials.gov ID
- NCT06758141
- Acronym / sponsor ID
- FJUH113381
- Conditions
- Satisfaction, Personal
- Keywords
- clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 3 Jan 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 objective of this study is to develop advanced cardiac models using 3D printing technology for teaching complex cardiology procedures such as (1) transseptal puncture, (2) cardiac ablation, and (3) ultrasound scanning and drainage of cardiac tamponade. By implementing this study, the investigators aim to transform the teaching methods for cardiology students at our hospital.
Detailed description
Background： The standard methodology for education in medicine, particularly in cardiology, still follows the apprenticeship model, where trainees observe, gradually take over, and practice under supervision until they can independently perform procedures. The traditional pedagogical strategy for complex medical procedures, like cardiac catheterization, emphasizes the "see one, do one, teach one" doctrine. Studies have revealed the superior efficacy of 3D printing in medical education, particularly in enhancing learning skills and knowledge among medical students. The demand for 3D printed models in medical education is increasing continuously.
Study Design：
This study is a single-center, pilot, prospective, randomized controlled educational trial.
Methods：
The trial will be conducted in the Department of Cardiovascular Medicine at Fu Jen Catholic University Hospital. The investigators plan to enroll 50 participants, who will be randomly assigned to either the 3D model training group (n=25) or the conventional curriculum group (n=25) in a 1:1 ratio. All participants will undergo pre- and post-training assessments, including a knowledge test (structured written questionnaire), an attitude assessment (semi-structured satisfaction questionnaire), and a skills evaluation (direct observation of procedural skills, DOPS).
Effect：
The investigators anticipate the development of a set of advanced 3D cardiac models for teaching cardiology procedures. It is expected that combining classroom learning with the viewing and interactive practice of 3D printed models will significantly improve the learning outcomes of the trainees.
Key words：
Clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed presention group | Experimental | Other: 3D printed educational modelReceived a routine presentation plus 3D printing model |
| Slide-based presention group | Active comparator | Other: Slide-based presentationReceived a routine presentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital
Key exclusion criteria (1 listed)
- Refused to participate in the study.
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 educational model3D Printed Advanced Cardiac Model | Other | 3D-printed presention group |
| Slide-based presentationSlide-based presentation | Other | Slide-based presention group |
Primary outcome
Examination score of pre-intervention
Time frame: pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome
Examination score of post-intervention
Time frame: immediately after the intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome
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 27 Feb 2026.
- 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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
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 educational model and Slide-based presentation in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
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 27 Feb 2026. 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 Taiwan. 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?
Examination score of pre-intervention (time frame: pre-intervention). The study lists 2 primary outcomes in all. 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 27 Feb 2026.