NCT05357716: PRE-ALERT

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Completed Last updated 4 October 2023

What this trial tests

trial testing HeartWatch in Atrial Fibrillation in 7 participants. Completed in 2 October 2023.

Timeline

15 November 2020

Primary endpoint
2 October 2023

2 October 2023

Quick facts

Lead sponsor	HelpWear Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	7
Start date	15 November 2020
Primary completion	2 October 2023
Estimated completion	2 October 2023
Sites	1 location across Canada

Drugs / interventions tested

• HeartWatch
• Event Recorder
• Holter Monitor

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Tachycardia, Supraventricular — all drugs for Tachycardia, Supraventricular →
• Bradyarrhythmia — all drugs for Bradyarrhythmia →
• Ventricular Arrythmia — all drugs for Ventricular Arrythmia →

Sponsor

HelpWear Inc.

Who can join

22 and older, any sex, with Atrial Fibrillation or Tachycardia, Supraventricular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.