Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)

  • days left to enroll
  • participants needed
  • sponsor
    HelpWear Inc.
Updated on 15 May 2022
holter monitor


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.

Condition Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
Treatment Holter monitor, HeartWatch, Event Recorder
Clinical Study IdentifierNCT05357716
SponsorHelpWear Inc.
Last Modified on15 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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