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Armband heart tracker takes on holter monitors

NCT ID NCT05357716

Diagnosis Sponsor: HelpWear Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether a wearable armband called HeartWatch can record heart rhythm data as well as standard Holter and event monitors. Adults who need extended heart rhythm monitoring wear the armband alongside a standard device for up to three days. The study checks whether the recordings match and how body position or activity affects signal quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HeartWatch wearable armband ECG recorder
What this could lead to
If the armband works, people with palpitations or fainting spells could get a comfortable, wire-free way to record their heart rhythm for days at a time.
What could go wrong
This is a small early study of 7 people, so it cannot prove the device works for everyone. Skin irritation or poor signal quality could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

7 people

The number who actually took part.

Started

Nov 2020

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive patients referred to participating clinics for extended ambulatory ECG testing. Subjects referred for extended ambulatory ECG testing will be recruited from the Toronto Heart Centre. Referring physicians will be asked to indicate if longer-term (i.e., Event Recorder) or shorter-term monitoring (i.e., Holter monitor) is desired for a given patient.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Bradycardia Tachycardia, Supraventricular

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Bradyarrhythmia Tachycardia, supraventricular Ventricular arrythmia

Contacts and locations

Locations

  • HelpWear Inc

    Toronto, Ontario, M5B1T8, Canada

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