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Clinical Trial 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.


Clinical Trial 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 high correlations 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 Design


Related Conditions & MeSH terms


NCT number NCT05970328
Study type Observational
Source Carré Technologies Inc.
Contact Yutian Shu, Ph.D.
Phone 888-887-2044
Email yutian.shu@carretechnologies.com
Status Recruiting
Phase
Start date July 24, 2023
Completion date April 24, 2024