Atrial FibrillationPRE-ALERTNCT05357716
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
An observational study of Atrial Fibrillation and Tachycardia, Supraventricular, run by HelpWear Inc. at 1 site in Canada.
Trial summary
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia
- What is being tested?
- HeartWatch, Event Recorder and Holter Monitor
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2020to 2 Oct 2023
- 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 to participating clinics for extended ambulatory ECG testing. Subjects referred for extended ambulatory ECG testing will be recruited from the Toronto Heart Centre. Referring physicians will be asked to indicate if longer-term (i.e., Event Recorder) or shorter-term monitoring (i.e., Holter monitor) is desired for a given patient.
Who may be able to join
- At least 22 years of age at time of consent
- Clinically-indicated for an ambulatory Event Recorder or Holter monitor
- Able to follow the protocol
- Provision of written-informed consent
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
Trial locations and contacts
1 site in 1 country.
About this study
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
- Being tested
- HeartWatch, Event Recorder, Holter Monitor
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWatchDevice
The HeartWatch arm band provides continuous, high-quality single lead electrocardiograph (ECG) data in a variety of environments. The ECG data is transmitted via Bluetooth and stored on the user's smartphone. It is then uploaded to the cloud for subsequent analysis using either a commercial ECG software package or a customized software package from HelpWear.
Event RecorderDevice
A standard 1 or 2-lead Sirona Event Recorder will be used to collect high-resolution data. Subjects will be asked to wear the clinical monitor for at least 48 hours and no longer than 84 hours. ECG signals will be continuously collected as long as the skin patches are attached to the skin and the recorder is properly connected to the wires.
Holter MonitorDevice
A standard 5-lead SEER Holter will be used to collect 3-channels of high-resolution data. Subjects will be asked to wear the clinical, conventional monitor for at least 36 hours and no longer than 60 hours. During this time ECG signals will be continuously collected.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Up to 40 patients will be enrolled in Arm A. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data. Receives: Device: HeartWatch; Device: Event Recorder | |
| Arm B | Up to 10 patients will be enrolled in Arm B.Subjects will wear the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Holter subjects will record diary information on their activities and any relevant symptoms. Receives: Device: HeartWatch; Device: Holter Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pairing HeartWatch and Event Recorder
Can paired user-triggered (tagged) and auto-triggered ECG data from the HeartWatch and Event Recorder be successfully collected?
Measured: Up to 6 months, with 3 months of analysis time (9 months total)
Pairing HeartWatch and Holter
Can paired continuous ECG data from the HeartWatch and Holter monitor be successfully collected?
Measured: Up to 6 months, with 3 months of analysis time (9 months total)
Secondary outcomes (1)
Body Position and Activity
Does body position and activity affect the quality of the HeartWatch, Event Recorder, and Holter data?
Measured: Up to 6 months, with 3 months of analysis time (9 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 Nov 2020
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- HelpWear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357716
- Sponsor's protocol ID
- 1.1
- Acronym
- PRE-ALERT
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
- ClinicalTrials.gov ID
- NCT05357716
- Acronym / sponsor ID
- PRE-ALERT / 1.1
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- HelpWear Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 3 May 2022 (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 clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Device: HeartWatch, Device: Event RecorderUp to 40 patients will be enrolled in Arm A. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data. |
| Arm B | – | Device: HeartWatch, Device: Holter MonitorUp to 10 patients will be enrolled in Arm B.Subjects will wear the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Holter subjects will record diary information on their activities and any relevant symptoms. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to participating clinics for extended ambulatory ECG testing. Subjects referred for extended ambulatory ECG testing will be recruited from the Toronto Heart Centre. Referring physicians will be asked to indicate if longer-term (i.e., Event Recorder) or shorter-term monitoring (i.e., Holter monitor) is desired for a given patient.
Key inclusion criteria (4 listed)
- At least 22 years of age at time of consent
- Clinically-indicated for an ambulatory Event Recorder or Holter monitor
- Able to follow the protocol
- Provision of written-informed consent
Key exclusion criteria (4 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
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 arm band provides continuous, high-quality single lead electrocardiograph (ECG) data in a variety of environments. The ECG data is transmitted via Bluetooth and stored on the user's smartphone. It is then uploaded to the cloud for subsequent analysis using either a commercial ECG software package or a customized software package from HelpWear. | Device | Arm A, Arm B |
| Event RecorderA standard 1 or 2-lead Sirona Event Recorder will be used to collect high-resolution data. Subjects will be asked to wear the clinical monitor for at least 48 hours and no longer than 84 hours. ECG signals will be continuously collected as long as the skin patches are attached to the skin and the recorder is properly connected to the wires. | Device | Arm A |
| Holter MonitorA standard 5-lead SEER Holter will be used to collect 3-channels of high-resolution data. Subjects will be asked to wear the clinical, conventional monitor for at least 36 hours and no longer than 60 hours. During this time ECG signals will be continuously collected. | Device | Arm B |
Primary outcome
Pairing HeartWatch and Event Recorder
Time frame: Up to 6 months, with 3 months of analysis time (9 months total)
Can paired user-triggered (tagged) and auto-triggered ECG data from the HeartWatch and Event Recorder be successfully collected?
Pairing HeartWatch and Holter
Time frame: Up to 6 months, with 3 months of analysis time (9 months total)
Can paired continuous ECG data from the HeartWatch and Holter monitor be successfully collected?
1 secondary outcome
Body Position and Activity
Time frame: Up to 6 months, with 3 months of analysis time (9 months total)
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.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Tachycardia, Supraventricular, 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 4 inclusion and 4 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?
Pairing HeartWatch and Event Recorder (time frame: Up to 6 months, with 3 months of analysis time (9 months total)). 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.