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New study: could a wearable heart monitor after fainting save lives?

NCT ID NCT05066347

Disease control Sponsor: Ottawa Hospital Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether using a portable heart monitor for 15 days after a fainting episode can detect dangerous heart rhythms that standard short-term monitoring might miss. About 580 adults who fainted and are at medium or high risk will be randomly assigned to either usual care or wearing the Cardiophone Plus device at home. The goal is to see if longer monitoring leads to better detection and treatment of heart rhythm problems, improving patient safety.

What this could mean

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

Active substance
Cardiophone Plus (portable heart monitor)
What this could lead to
If successful, this could show that longer home monitoring after fainting helps catch hidden heart rhythm problems early, potentially preventing serious events.
What could go wrong
This is a relatively small, early-stage trial focused on detection, not treatment. The device may not catch all dangerous rhythms, and false alarms could cause unnecessary worry or tests.

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 580 people

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

Started

Jul 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: * Adult patients (aged ≥ 18 years old) who present with syncope to any of the study EDs (within 24 hours), are classified as medium (3-5,) or high-risk (≥6) as per the CSRS and are being discharged from the ED either by the ED team or the consulting team if consulted to another service. Patients will be enrolled after written consent. * For the secondary objectives related to the embedded observational study, validation of the CSRS ultra-low-risk criteria and to evaluate if the CSRS can be updated to improve its accuracy, ED physicians will obtain verbal consent from patients who are lower risk (score \<3). These patients will not be enrolled in the randomized controlled trial. Exclusion Criteria: * Prolonged loss of consciousness (i.e., \> 5 minutes), * Glasgow Coma Scale \< 15 in patients without dementia (or a change in the mental status from baseline in those with dementia); * Witnessed obvious seizure, or head trauma preceding the loss of consciousness; and those who are unable to provide proper details (e.g., alcohol intoxication or other substance use). * Patients who are hospitalized on their index ED visit and who had an obvious underlying serious condition for the syncope identified during the index ED visit

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Conditions

The condition(s) this trial relates to.

Emergencies Syncope syncope, familial vasovagal

As listed by the trial registrant

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

Syncope

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

  • The Ottawa Hospital - Civic and General Campuses

    RECRUITING

    Ottawa, Ontario, K1Y 4E9, Canada

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