Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Atrial Fibrillation Clinical Trial

— PRE-ALERT  

Official title:

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357716
• Other study ID #: 1.1
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: October 2, 2023

Study information

• Verified date: April 2022
• Source: HelpWear Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradyarrhythmia
• Bradycardia
• Tachycardia
• Tachycardia, Supraventricular
• Ventricular Arrythmia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	HelpWear Inc	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
HelpWear Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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)
Primary	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	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)