Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients (MAPS)

ZOLL Medical

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Device: Arrhythmia Management System (AMS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04754204

90D0234

Details and patient eligibility

About

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

Full 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.

Enrollment: 585 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

585 participants in 1 patient group

Patients indicated for Mobile Cardiac Telemetry Monitoring

Description:

Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner.

Treatment:

Device: Arrhythmia Management System (AMS)