ALERT
Ambulatory Leadless Electrocardiogram Recorder Trial
Active Sites at the Foothills Medical Centre, Peter Lougheed Centre & South Health Centre
Objective
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.
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Inclusion
- 22> years old
- Clinically indicated for an ambulatory Event Recorder or Holter monitor test
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Exclusion
- Known allergies to any component of the Heartwatch
- Known allergies to any component of the Holter Monitor
- Known allergies to any component of the Event Recorder
- Dextrocardia
Additional Info
Ethics ID: REB23-0389
ClinicalTrials.gov ID: NCT05821465
Sponsor: Helpwear Inc.
PI: Dr. Russell Quinn | 403 220 5500 | frquinn@ucalgary.ca
Admins:
FMC: Shivani Sehrawat | 403 216 7386 | shivani.sehrawat@ucalgary.ca
SHC: Joel Angihan | 403 956 2683 | jangihan@ucalgary.ca
PLH: To be determined...
Updated Sept 19, 2023