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OpenTrials
Completed

NCT Number: NCT04754204

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

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

Completed

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cardiovascular Medical Group, Bakersfield, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arrhythmia Management System (AMS)

Device

AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

Primary outcomes

  1. Biometric Data Associations to Arrhythmias

    Time frame: 30 days

    MCT Data Sets

  2. Biometric Data Associations to Subject-Reported Symptoms

    Time frame: 30 days

    MCT Data Sets

  3. Biometric Data Associations to Subject Wellness

    Time frame: 30 days

    MCT Data Sets

Secondary outcomes

  1. Clinician Use of Biometric Data Associations to Arrhythmias

    Time frame: 30 days

    Clinical Case Report Forms

  2. Clinician Use of Biometric Data Associations to Subject-Reported Symptoms

    Time frame: 30 days

    Clinical Case Report Forms

  3. Clinician Use of Biometric Data Associations to Wellness Status of Subject

    Time frame: 30 days

    Clinical Case Report Forms

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device

Acronym: MAPS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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