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Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility

NCT05821465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2024-07-22

No results posted yet for this study

Summary

The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question\[s\] it aims to answer are:

1. Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices?
2. Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.

Conditions

  • Arrhythmias, Cardiac
  • Palpitation
  • Syncope
  • Light Headedness

Interventions

DEVICE

HeartWatch

The HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session.

Sponsors & Collaborators

  • HelpWear Inc.

    lead INDUSTRY

Principal Investigators

  • Derek Exner, MD · HelpWear Inc.

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-07-18
Completion
2024-07-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05821465 on ClinicalTrials.gov