Comparison of a Torso-Based Derived 6-Lead Electrocardiogram (ECG) Device With Standard 12-Lead Electrocardiogram (ECG) in Healthy Volunteers

NCT07277374 | Completed

• 1 other identifier: HNH-KAEK 2023/KK/193
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare electrocardiographic interval measurements obtained from a torso-placed six-lead electrocardiogram (ECG) device (torso-derived ECG; T-ECG) with those obtained from a standard 12-lead electrocardiogram (ECG) in healthy adult volunteers. The torso-derived device synthesizes limb-lead signals using electrodes positioned on the thorax, potentially allowing for faster and more practical ECG acquisition in emergency department settings, operating rooms, and prehospital environments. A total of 24 participants undergo both standard 12-lead ECG recording and torso-derived 6-lead ECG recording during the same study session. Heart rate (HR), PR interval, QRS duration, QT interval, and corrected QT (QTc) values are analyzed using Bland-Altman agreement analysis and correlation testing. The study also evaluates whether anthropometric characteristics-including body mass index (BMI)-influence the compatibility and agreement between the two measurement systems.

Conditions

Healthy Volunteer

Keywords

Electrocardiography; 6-lead ECG; 12-lead ECG; Torso ECG; ECG comparison

Outcome Measures

Primary Outcomes (4)

• PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)

  Mean difference in PR interval between torso-derived six-lead electrocardiogram (ECG) and standard 12-lead ECG recordings obtained during the same resting session. Single-session baseline ECG recording.

  Single-session baseline ECG recording.

• QRS Duration Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)

  Mean difference in QRS duration between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session

  Single-session baseline ECG recording.

• QT Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)

  Mean difference in QT interval between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.

  Single-session baseline ECG recording

• Heart Rate (HR) Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)

  Mean difference in heart rate (HR) between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.

  Single-session baseline ECG recording.

Secondary Outcomes (1)

• Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements

  Single-session recording (baseline only)

Study Arms (1)

Healthy Volunteer ECG Group

Participants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis.

Device: Torso-Based 6-Lead ECG Recording

Interventions

Torso-Based 6-Lead ECG Recording DEVICE

Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.

Healthy Volunteer ECG Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy adult volunteers without known cardiovascular disease. All participants undergo both standard 12-lead electrocardiogram (ECG) recording and torso-derived 6-lead electrocardiogram (ECG) recording during a single study session. Participants are screened prior to inclusion to ensure the absence of baseline arrhythmia, ischemia, conduction delay, or structural heart disease.

You may qualify if:

• Age between 18 and 65 years
• No known cardiovascular disease
• No arrhythmia, conduction disorder, or ischemic electrocardiogram (ECG) changes at baseline
• Willingness to participate and ability to provide written informed consent

You may not qualify if:

• Known cardiac disease, including coronary artery disease (CAD), arrhythmia, heart failure, or valvular heart disease
• Pacemaker rhythm or baseline abnormal electrocardiogram (ECG) findings
• Thoracic deformity or prior thoracic surgery that prevents appropriate electrode placement
• Unwillingness to participate or inability to provide informed consent

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpaşa Numune Training and Research Hospital - Emergency Medicine Department

Istanbul, 34668, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 11, 2025
• Study Start: December 6, 2023
• Primary Completion: March 6, 2024
• Study Completion: June 6, 2024
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)