Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
ID06164808

Cardiac Arrhythmia Telemetry Comparing Conventional Holter Monitor and HeartWatch Device

Led by HelpWear Inc. · Updated on 2026-05-27

205

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Heart rhythm disorders such as atrial fibrillation, atrial flutter, supraventricular tachycardia, bradycardia, and ventricular arrhythmias affect many people and can significantly impact their lives and families. Detecting these conditions is challenging with current devices, which are either worn for short periods or require invasive implantation. This trial compares a new longer-term monitoring device called HeartWatch, worn on the upper arm and paired with a smartphone app, against the conventional Holter monitor to evaluate their accuracy and reliability in detecting heart electrical signals. Participants referred for a Holter monitor test will wear both the Holter monitor and the HeartWatch simultaneously for 24 to 48 hours. HeartWatch is an armband device worn on the left upper arm that collects heart signals and uploads them securely for analysis via a paired smartphone app. The study will compare the quality of signal detection and heart electrical measurements between the two devices and assess adverse events and patient preferences. During the study, participants will be monitored while wearing both devices for up to two days. Researchers will evaluate heart signal characteristics such as QRS complex detection and ECG intervals during this time. Participants will provide written consent and must be able to wear the HeartWatch on their left arm. Safety and device performance will be closely monitored, and the total participation time corresponds to the device wear period of 24 to 48 hours.

CONDITIONS

Brief Title

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 between 22 cm and 45 cm
  • Provision of written-informed consent
Not Eligible

You will not qualify if you...

  • 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 (e.g., functional AV fistula, prior carcinoma with lymph node dissection or lymphedema, known blood clots, chronic neuropathic pain)
  • Dextrocardia
  • Implanted functional Pacemaker or Defibrillator
  • Left bicep circumference less than 22 cm
  • Left bicep circumference greater than 45 cm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 24 to 48 hours

Participants wear both the conventional Holter monitor and the HeartWatch device simultaneously to collect heart electrical signals for comparison.

1 to 2 monitoring visits depending on device placement and removal

Trial Site Locations

Total: 1 location

1

Foothills Medical Centre University of Calgary

Calgary, Alberta, Canada, T2N 4N1

Actively Recruiting

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Research Team

K

Karen Cowan

O

Owen Gillett

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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