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Clinical Trials in Canada / NCT06164808
Recruiting Not applicable

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

NCT06164808 · tracked via the Priya Life Science Canada tracker
Sponsor
HelpWear Inc
Phase
Not applicable
Started
2024-02-20
Last updated
2026-06-09

Condition(s) studied

Cardiac ArrhythmiaDiagnostic/Monitoring Devices Related to Adverse IncidentsAtrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

HeartWatch

HeartWatch: The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis.

Study 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) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Foothills Medical Centre University of Calgary Calgary Alberta Recruiting

More HelpWear Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06164808 on ClinicalTrials.gov ↗ ← All trials in Canada