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Armband could replace holter monitors for heart arrhythmia detection

NCT ID NCT06164808

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new wearable armband called HeartWatch to the standard Holter monitor for detecting heart rhythm problems like atrial fibrillation. About 300 adults who need a Holter test will wear both devices at the same time. The goal is to see if the HeartWatch can accurately capture heart signals and help doctors spot arrhythmias more easily.

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 (wearable device)
What this could lead to
If successful, this could provide a comfortable, non-invasive way to monitor heart rhythms for longer periods, helping detect hard-to-find arrhythmias.
What could go wrong
This is a small, early-stage device comparison study, not a treatment trial. The HeartWatch may not match Holter accuracy, and results may not apply to all patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

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 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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation disease ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

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

Atrial fibrillation (AF) Cardiac arrhythmia Diagnostic/monitoring devices related to adverse incidents

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Foothills Medical Centre University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 4N1, Canada

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