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Armband heart monitor takes on the holter in Head-to-Head test

NCT ID NCT05821465

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new arm-worn heart monitor called the HeartWatch can record heart rhythms as well as the Holter and event recorders used in clinics. Adults who have been recommended for a heart monitor wear the HeartWatch on the upper left arm at the same time as their standard monitor. The study compares how well each device detects and classifies abnormal heart rhythms and QRS complexes, and it tracks any side effects and device preference.

What this could mean

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

Active substance
HeartWatch armband heart monitor
What this could lead to
If it works, the HeartWatch could offer a simpler arm-worn option for people who need their heart rhythm checked over a day or two.
What could go wrong
The device may miss or misread heart rhythms compared with standard monitors, and this early feasibility study in 144 people cannot prove it works for everyone.

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

144 people

The number who actually took part.

Started

Jul 2023

Finished

Jul 2024

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 for extended ambulatory ECG monitoring will be approached for participation. A total of 150 subjects will be enrolled into the two parallel studies, 50 subjects in the HeartWatch vs Event recorder and 100 subjects in HeartWatch vs Holter monitor.

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 Event Recorder or Holter * Able to follow the protocol * Provision of written-informed consent * No functional implantable pacemaker or defibrillator * Left bicep circumference \> 22 cm and \< 45 cm 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 * Implanted functional Pacemaker of Defibrillator * Left bicep circumference \< 22 cm * Left bicep circumference \> 45 cm

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease Dizziness Syncope

As listed by the trial registrant

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

Arrhythmias, cardiac Light headedness Palpitation Syncope

Contacts and locations

Locations

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4N1, Canada

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