Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Completed

• Conditions: Bradyarrhythmia; Ventricular Arrythmia; Atrial Fibrillation; Tachycardia, Supraventricular
• Interventions: Device: HeartWatch; Device: Event Recorder; Device: Holter Monitor

• Registration Number: NCT05357716
• Lead Sponsor: HelpWear Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-02
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	Event Recorder	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.
Arm B	HeartWatch	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.
Arm A	HeartWatch	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.
Arm B	Holter Monitor	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.

Primary Outcome Measures

Name	Time	Method
Pairing HeartWatch and Event Recorder	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	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?

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HelpWear Inc; 🇨🇦 Toronto, Ontario, Canada