Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Zoll Medical Corporation
- Enrollment
- 585
- Locations
- 20
- Primary Endpoint
- Biometric Data Associations to Arrhythmias
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Biometric Data Associations to Arrhythmias
Time Frame: 30 days
MCT Data Sets
Biometric Data Associations to Subject-Reported Symptoms
Time Frame: 30 days
MCT Data Sets
Biometric Data Associations to Subject Wellness
Time Frame: 30 days
MCT Data Sets
Secondary Outcomes
- Clinician Use of Biometric Data Associations to Subject-Reported Symptoms(30 days)
- Clinician Use of Biometric Data Associations to Arrhythmias(30 days)
- Clinician Use of Biometric Data Associations to Wellness Status of Subject(30 days)