Status:
ACTIVE_NOT_RECRUITING
Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Lead Sponsor:
HelpWear Inc.
Conditions:
Cardiac Arrhythmia
Diagnostic/Monitoring Devices Related to Adverse Incidents
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) ...
Detailed Description
Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of si...
Eligibility Criteria
Inclusion
- At least 22 years of age at time of consent
- Clinically indicated for a Holter monitor test
- Able to wear the HeartWatch on the left bicep for the study duration
- Able to follow the protocol
- No functional implantable pacemaker or defibrillator
- Left bicep circumference \>/= 22 cm and \</= 45 cm
- Provision of written-informed consent
Exclusion
- Known allergy to any component of the Holter monitor
- Known allergy to any component of the HeartWatch
- Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
- Dextrocardia
- Implanted functional Pacemaker or Defibrillator
- Left bicep circumference \< 22 cm
- Left bicep circumference \< 45 cm
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06164808
Start Date
February 20 2024
End Date
October 1 2024
Last Update
July 23 2024
Active Locations (1)
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1
Foothills Medical Centre University of Calgary
Calgary, Alberta, Canada, T2N 4N1