Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

  • STATUS
    Recruiting
  • End date
    Mar 12, 2022
  • participants needed
    1500
  • sponsor
    Zoll Medical Corporation
Updated on 12 June 2021
arrhythmia

Summary

To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

Description

The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.

Details
Condition Arrhythmia, Atrial Flutter, Atrial Fibrillation, Heart disease, Premature ventricular contractions, Bradycardia, Atrial Fibrillation (Pediatric), Dysrhythmia, Cardiac Disease, ventricular extrasystoles, cardiac arrhythmia, cardiac dysrhythmias, arrhythmias, cardiac arrhythmias, dysrhythmias, abnormal heart rhythms, Non-Lethal Cardiac Arrhythmia, Non-Lethal Cardiac Arrhythmia
Treatment Arrhythmia Management System (AMS)
Clinical Study IdentifierNCT04754204
SponsorZoll Medical Corporation
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects who require monitoring for non-lethal cardiac arrhythmias
Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
Subjects 21 years of age or older

Exclusion Criteria

Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
Subjects currently hospitalized
Subjects with a skin condition preventing them from wearing the AMS device
Subjects who are non-ambulatory
Subjects who are self-reporting to be pregnant
Subjects participating in another study
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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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