Status:
COMPLETED
Hexoskin Medical System - ECG Performance Testing
Lead Sponsor:
Carré Technologies Inc.
Conditions:
Cardiac Rhythm Disturbance
Eligibility:
All Genders
21-100 years
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 adul...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 17 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05970328
Start Date
July 24 2023
End Date
February 17 2024
Last Update
August 21 2024
Active Locations (2)
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1
Lawrence Park Cardiology
Toronto, Ontario, Canada, M4N 3N1
2
Yorkview Cardiology
North York, Canada