Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

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

Detailed Description
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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.

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

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: Arrhythmia Management System (AMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients indicated for Mobile Cardiac Telemetry Monitoring<br>Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner. | Device: Arrhythmia Management System (AMS)<br>* AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biometric Data Associations to Arrhythmias | MCT Data Sets | 30 days | 
| Biometric Data Associations to Subject-Reported Symptoms | MCT Data Sets | 30 days | 
| Biometric Data Associations to Subject Wellness | MCT Data Sets | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Use of Biometric Data Associations to Arrhythmias | Clinical Case Report Forms | 30 days | 
| Clinician Use of Biometric Data Associations to Subject-Reported Symptoms | Clinical Case Report Forms | 30 days | 
| Clinician Use of Biometric Data Associations to Wellness Status of Subject | Clinical Case Report Forms | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac, arrhythmia