3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction, Personal
• Intervention / Treatment: Other: 3D printed educational model; Other: Slide-based presentation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital

Exclusion Criteria:

• Refused to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-printed presention group; Received a routine presentation plus 3D printing model	Other: 3D printed educational model; 3D Printed Advanced Cardiac Model
Active Comparator: Slide-based presention group; Received a routine presentation	Other: Slide-based presentation; Slide-based presentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination score of pre-intervention	score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome	pre-intervention
Examination score of post-intervention	score of post-intervention (maximun 100 and minimum 0), higher means a better outcome	immediately after the intervention

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): January 8, 2025
• Study Completion (Actual): January 8, 2025

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac ablation; cardiac tamponade; clinical simulation-based education; advanced cardiology procedures; transseptal puncture
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Behavior; Cardiac Tamponade; Personal Satisfaction
• Other Study ID Numbers: FJUH113381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No