NCT06164808

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: HelpWear Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

Detailed description

Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Conditions

• Cardiac Arrhythmia
• Diagnostic/Monitoring Devices Related to Adverse Incidents

Interventions

Type	Name	Description
DEVICE	HeartWatch	The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis.

Timeline

• Start date: 2024-02-20
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2023-12-11
• Last updated: 2024-07-23

Locations

1 site across 1 country: Canada