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

NCT ID: NCT06758141

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-07-31

Brief 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. 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.

Conditions

Satisfaction, Personal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

3D-printed presention group

Received a routine presentation plus 3D printing model

Group Type: EXPERIMENTAL

3D printed educational model

Intervention Type: OTHER

3D Printed Advanced Cardiac Model

Slide-based presention group

Received a routine presentation

Group Type: ACTIVE_COMPARATOR

Slide-based presentation

Intervention Type: OTHER

Slide-based presentation

Interventions

3D printed educational model

3D Printed Advanced Cardiac Model

Intervention Type: OTHER

Slide-based presentation

Slide-based presentation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Refused to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fu Jen Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Ke-Yun, Chao

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University

Locations

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ke-Yun Chao, PhD

Role: CONTACT

ck_qq@hotmail.com

+886905301879

Facility Contacts

Ke-Yun Chao, PhD

Role: primary

ck_qq@hotmail.com

+886-905-301-879

Other Identifiers

FJUH113381

Identifier Type: -

Identifier Source: org_study_id