Hexoskin Medical System - ECG Performance Testing

Completed

• Conditions: Cardiac Rhythm Disturbance
• Interventions: Device: Hexoskin Medical System

• Registration Number: NCT05970328
• Lead Sponsor: Carré Technologies Inc.

Brief Summary

The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Detailed Description

The main questions it aims to answer are:

1. Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor

2. Whether there are good agreements between the HMS and Holter monitor in ECG characteristics

3. Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor

4. What is the accuracy of using HMS ECG recordings to detect cardiac beats

5. What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm disturbance

Participants will wear the HMS and the Holter monitor at the same time to record ECG signals. Researchers will evaluate the ECG recordings acquired from both devices and assess the above questions.

Study Timeline

• Study First Submitted: 2023-07-21
• Study Start: 2023-07-24
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-01
• Primary Completion: 2024-02-17
• Study Completion: 2024-02-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 21 years or older.
• Participants must be suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Exclusion Criteria

• Body circumference that is not covered by the HMS Shirt sizing chart
• Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices
• Known allergic reactions to silver or polyamide/polyester/elastane
• Known allergic reactions to ECG gel electrodes
• Documented medical condition or illness requiring intensive medical treatment or care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arrhythmia Participant	Hexoskin Medical System	Non-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Primary Outcome Measures

Name	Time	Method
ECG characteristics measurement agreement	2 days	The agreement (Bland-Altman plots) of Holter monitor(reference standard) and HMS to measure each of the four (4) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), and QRS Duration (ms).

Secondary Outcome Measures

Name	Time	Method
Heart rate agreement	2 days	The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor.

Trial Locations

Locations (2)

Lawrence Park Cardiology; 🇨🇦 Toronto, Ontario, Canada

Yorkview Cardiology; 🇨🇦 North York, Canada