Status:
COMPLETED
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
21+ years
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 prov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT04754204
Start Date
December 15 2020
End Date
December 15 2021
Last Update
February 9 2022
Active Locations (20)
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1
Comprehensive Cardiovascular Medical Group
Bakersfield, California, United States, 93309
2
Cardiovascular Innovation and Research Center
Long Beach, California, United States, 90813
3
Heartbeat Cardiovascular Medical Group
Los Angeles, California, United States, 90027
4
Interventional Cardiology Group
West Hills, California, United States, 91307