Arrhythmias, CardiacALERTNCT05821465
Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility
An observational study of Arrhythmias, Cardiac and Palpitation, run by HelpWear Inc. at 1 site in Canada.
Trial summary
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Palpitation, Syncope
- What is being tested?
- HeartWatch
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 18 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambulatory Leadless Electrocardiogram Recorder Trial (ALERT Feasibility)
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question[s] it aims to answer are:
- Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices?
- Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.
Read the detailed description
Two general types of consumer products are used to monitor patients with or at risk of heart rhythm disorders. Most estimate heart rhythm using blood flow (photoplethysmography) alone or in combination with activity sensors (accelerometer). These methods are not reliable in detecting heart rhythm abnormalities. Other methods record an ECG when the patient has symptoms. These devices are useful, but require the wearer to recognize their symptoms, attach the device and rest quietly to obtain an ECG recording of reasonable quality. The user then needs to send that information to a healthcare provider to verify. Hence, these consumer-based technologies are far from ideal. However, the diagnostic accuracy of single-lead ECG via wearable medical devices is excellent and, likely superior to a family physician's interpretation of a 12-lead ECG.3 High-quality ECG data from wearable devices that can unequivocally document AF can expedite its detection, allowing prompt diagnosis and appropriate prescription of antithrombotic and other therapies.
The HeartWatch arm band is designed to provide non-invasive, continuous single lead ECG data, irrespective of activity, the environment, and other factors. It continuously records ECG data for subsequent, offline analysis. The HeartWatch allows the user to note (flag) any symptoms they experience (e.g., palpitations, light-headedness, fainting, etc…) to allow for symptom-rhythm correlation and subsequent review by a physician. The HeartWatch displays all the elements of an ECG signal (i.e., PQRST) to facilitate diagnoses by physicians and is comparable to lead I of a traditional ECG system.
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.
The primary purpose of the study is to compare the interpretability of all tagged and all non-normal clinically significant arrhythmia events and the detection of QRS complexes by the HeartWatch, an upper armbased, ambulatory, single lead ECG collection tool, vs. conventional Event Recorder or Holter monitor reference device.
- Conditions
- Arrhythmias, Cardiac, Palpitation, Syncope, Light Headedness
- Being tested
- HeartWatch
- Medical subject headings
- Arrhythmias, Cardiac, Syncope, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWatchDevice
The HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session.
| Study group | Role | What they receive |
|---|---|---|
| HeartWatch vs. Event Recorder | All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Event Recorder) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions. Receives: Device: HeartWatch | |
| HeartWatch vs. Holter | All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Holter) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions. Receives: Device: HeartWatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
HeartWatch arrhythmia event characterization accuracy
An arrhythmia diagnosis will be applied to all patient-tagged (symptomatic) events (HeartWatch, Event Recorder, and Holter) and all abnormal significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). For the HeartWatch to be considered comparable to the Holter and Event Recorder, the accuracy of the HeartWatch to categorize the correct arrhythmia must be > 85% of the combined Holter and Event Recorder data.
Measured: Events will be assessed for the duration of time each participants wears the HeartWatch and holter/event recorder, up to 48 hours.
HeartWatch recording accuracy of QRS complexes
To be considered comparable to the Holter, the HeartWatch must detect > 90% of the QRS complexes recorded on the Holter lead I reference ECG signal
Measured: QRS complexes will be assessed for the duration of time each participants wears the HeartWatch and the holter monitor up to 48 hours.
Secondary outcomes (4)
Does the HeartWatch differ from the Event Recorder and Holter monitor in terms of adverse events?
The incidence of adverse events will be collected and compared between the HeartWatch vs the standard heart monitors
Measured: Events will be assessed up to 48 hours of the patient wearing the HeartWatch.
Evaluate if the HeartWatch will be similarly preferred to the Event Recorder and Holter monitor.
Subjects will complete a questionnaire that will allow them to indicate their user preference on reture of the device.
Measured: Up to 48 hours
The 10-minute averaged and paired PR/QRS intervals from the HeartWatch will be within 20 msec of the 10-minute averaged PR/QRS intervals from lead I of the Holter for at the same time points
The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear
Measured: Up to 48 hours.
the 10-minute averaged and paired QT intervals from the HeartWatch will be within 40 msec of the 10-minute averaged QT intervals from lead I of the Holter.
The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear
Measured: Up to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jul 2023
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- HelpWear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek Exner, MD, Study director, HelpWear Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821465
- Sponsor's protocol ID
- V2.0
- Acronym
- ALERT
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Leadless Electrocardiogram Recorder Trial (ALERT Feasibility)
- ClinicalTrials.gov ID
- NCT05821465
- Acronym / sponsor ID
- ALERT / V2.0
- Conditions
- Arrhythmias, Cardiac, Palpitation, Syncope, Light Headedness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- HelpWear Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question[s] it aims to answer are:
- Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices?
- Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.
Detailed description
Two general types of consumer products are used to monitor patients with or at risk of heart rhythm disorders. Most estimate heart rhythm using blood flow (photoplethysmography) alone or in combination with activity sensors (accelerometer). These methods are not reliable in detecting heart rhythm abnormalities. Other methods record an ECG when the patient has symptoms. These devices are useful, but require the wearer to recognize their symptoms, attach the device and rest quietly to obtain an ECG recording of reasonable quality. The user then needs to send that information to a healthcare provider to verify. Hence, these consumer-based technologies are far from ideal. However, the diagnostic accuracy of single-lead ECG via wearable medical devices is excellent and, likely superior to a family physician's interpretation of a 12-lead ECG.3 High-quality ECG data from wearable devices that can unequivocally document AF can expedite its detection, allowing prompt diagnosis and appropriate prescription of antithrombotic and other therapies.
The HeartWatch arm band is designed to provide non-invasive, continuous single lead ECG data, irrespective of activity, the environment, and other factors. It continuously records ECG data for subsequent, offline analysis. The HeartWatch allows the user to note (flag) any symptoms they experience (e.g., palpitations, light-headedness, fainting, etc…) to allow for symptom-rhythm correlation and subsequent review by a physician. The HeartWatch displays all the elements of an ECG signal (i.e., PQRST) to facilitate diagnoses by physicians and is comparable to lead I of a traditional ECG system.
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.
The primary purpose of the study is to compare the interpretability of all tagged and all non-normal clinically significant arrhythmia events and the detection of QRS complexes by the HeartWatch, an upper armbased, ambulatory, single lead ECG collection tool, vs. conventional Event Recorder or Holter monitor reference device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartWatch vs. Event Recorder | – | Device: HeartWatchAll patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Event Recorder) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions. |
| HeartWatch vs. Holter | – | Device: HeartWatchAll patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Holter) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartWatchThe HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session. | Device | HeartWatch vs. Event Recorder, HeartWatch vs. Holter |
Primary outcome
HeartWatch arrhythmia event characterization accuracy
Time frame: Events will be assessed for the duration of time each participants wears the HeartWatch and holter/event recorder, up to 48 hours.
An arrhythmia diagnosis will be applied to all patient-tagged (symptomatic) events (HeartWatch, Event Recorder, and Holter) and all abnormal significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). For the HeartWatch to be considered comparable to the Holter and Event Recorder, the accuracy of the HeartWatch to categorize the correct arrhythmia must be > 85% of the combined Holter and Event Recorder data.
HeartWatch recording accuracy of QRS complexes
Time frame: QRS complexes will be assessed for the duration of time each participants wears the HeartWatch and the holter monitor up to 48 hours.
To be considered comparable to the Holter, the HeartWatch must detect > 90% of the QRS complexes recorded on the Holter lead I reference ECG signal
4 secondary outcomes
Does the HeartWatch differ from the Event Recorder and Holter monitor in terms of adverse events?
Time frame: Events will be assessed up to 48 hours of the patient wearing the HeartWatch.
Evaluate if the HeartWatch will be similarly preferred to the Event Recorder and Holter monitor.
Time frame: Up to 48 hours
The 10-minute averaged and paired PR/QRS intervals from the HeartWatch will be within 20 msec of the 10-minute averaged PR/QRS intervals from lead I of the Holter for at the same time points
Time frame: Up to 48 hours.
the 10-minute averaged and paired QT intervals from the HeartWatch will be within 40 msec of the 10-minute averaged QT intervals from lead I of the Holter.
Time frame: Up to 48 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Exner, MD study director
HelpWear Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Palpitation, run by HelpWear Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HeartWatch arrhythmia event characterization accuracy (time frame: Events will be assessed for the duration of time each participants wears the HeartWatch and holter/event recorder, up to 48 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.