Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Tachycardia, Supraventricular; Ventricular Arrythmia; Bradyarrhythmia
• Intervention / Treatment: Device: HeartWatch; Device: Event Recorder; Device: Holter Monitor

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

• Study Contact: Name: Nabil Uddin; Phone Number: 6478632420; Email: nabil.uddin@helpwear.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1T8
      • HelpWear Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: HeartWatch; 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.; Device: Event Recorder; 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.
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.	Device: HeartWatch; 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.; Device: Holter Monitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pairing HeartWatch and Event Recorder	Can paired user-triggered (tagged) and auto-triggered ECG data from the HeartWatch and Event Recorder be successfully collected?	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?	Up to 6 months, with 3 months of analysis time (9 months total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Position and Activity	Does body position and activity affect the quality of the HeartWatch, Event Recorder, and Holter data?	Up to 6 months, with 3 months of analysis time (9 months total)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of adverse events among the HeartWatch and comparator devices and the types of adverse events	Up to 6 months, with 3 months of analysis time (9 months total)
User Preferences	User preferences of subjects with the HeartWatch versus the comparator devices	Up to 6 months, with 3 months of analysis time (9 months total)

Collaborators and Investigators

• Sponsor: HelpWear Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Bradycardia; Tachycardia; Tachycardia, Supraventricular
• Other Study ID Numbers: 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No