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Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility
Sponsor: HelpWear Inc.
Summary
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question\[s\] it aims to answer are: 1. Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices? 2. Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.
Official title: Ambulatory Leadless Electrocardiogram Recorder Trial (ALERT Feasibility)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
144
Start Date
2023-07-01
Completion Date
2024-07-18
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
HeartWatch
The HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session.
Locations (1)
Foothills Medical Centre
Calgary, Alberta, Canada