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.
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 Type
OBSERVATIONAL
Enrollment
75
Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.
Lawrence Park Cardiology
Toronto, Ontario, Canada
Yorkview Cardiology
North York, Canada
ECG characteristics measurement agreement
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).
Time frame: 2 days
Heart rate agreement
The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor.
Time frame: 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.