Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

NCT05357716 | Completed

• 1 other identifier: 1.1
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Body Position and Activity

  Up to 6 months, with 3 months of analysis time (9 months total)

Other Outcomes (2)

• Adverse Events

  Up to 6 months, with 3 months of analysis time (9 months total)

• User Preferences

  Up to 6 months, with 3 months of analysis time (9 months total)

Study Arms (2)

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; 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.

Device: HeartWatch; Device: Holter Monitor

Interventions

HeartWatch DEVICE

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.

Arm A; Arm B

Event Recorder DEVICE

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 A

Holter Monitor DEVICE

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.

Arm B

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HelpWear Inc.: lead

Study Sites (1)

HelpWear Inc

Toronto, Ontario, M5B1T8, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Supraventricular; Bradycardia

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: November 15, 2020
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: October 4, 2023

Record last verified: 2022-04

Locations

CA (1)