Status:
COMPLETED
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
Lead Sponsor:
HelpWear Inc.
Conditions:
Atrial Fibrillation
Tachycardia, Supraventricular
Eligibility:
All Genders
22+ years
Brief Summary
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indi...
Eligibility Criteria
Inclusion
- At least 22 years of age at time of consent
- Clinically-indicated for an ambulatory Event Recorder or Holter monitor
- Able to follow the protocol
- Provision of written-informed consent
Exclusion
- Known allergy to any component of the Event Recorder
- Known allergy to any component of the Holter monitor
- Known allergy to any component of the HeartWatch
- Dextrocardia
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05357716
Start Date
November 15 2020
End Date
October 2 2023
Last Update
October 4 2023
Active Locations (1)
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1
HelpWear Inc
Toronto, Ontario, Canada, M5B1T8