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

NCT07277374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

DEVICE

Torso-Based 6-Lead ECG Recording

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

Sponsors & Collaborators

  • Haydarpasa Numune Training and Research Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-03-06
Completion
2024-06-06

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277374 on ClinicalTrials.gov