Recruiting

HeartWatch

Sponsor:

HelpWear Inc.

Code:

NCT06164808

Conditions

Cardiac Arrhythmia

Diagnostic/Monitoring Devices Related to Adverse Incidents

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

HeartWatch

Study Details

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) 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.

Conditions

Cardiac Arrhythmia

Diagnostic/Monitoring Devices Related to Adverse Incidents

Atrial Fibrillation (AF)

Study ID

NCT06164808

Start date

Feb 20, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Active device engagement

All subjects will wear either the Holter monitor and the HeartWatch.

Interventions

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.

Primary outcome measure

  • QRS signal detection [ Time Frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours ]

Central Contacts and Locations

Central contacts

Karen Cowan

4035600225kcowan@ucalgary.ca

Owen Gillett

647-994-4077owen.gillett@helpwear.ca

Locations

Foothills Medical Centre University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Russell Quinn, MD

403-220-5500frquinn@ucalgary.ca

More Information

Sponsor

HelpWear Inc.

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HelpWear Inc. on 2026-06-09.