An observational study in Arrhythmias, Cardiac, Palpitation and Syncope, sponsored by HelpWear Inc.. Completed at 1 site in Canada. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by HelpWear Inc. · Observational
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:
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 144 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →HelpWear Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: HeartWatch
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.
Device: HeartWatch
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.
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.
Time frame: 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
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.
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
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.
Subjects will complete a questionnaire that will allow them to indicate their user preference on reture of the device.
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
The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear
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.
The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear
Time frame: Up to 48 hours.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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