Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients
- Conditions
- Cardiac Arrhythmia
- Interventions
- Device: Arrhythmia Management System (AMS)
- Registration Number
- NCT04754204
- Lead Sponsor
- Zoll Medical Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 585
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients indicated for Mobile Cardiac Telemetry Monitoring Arrhythmia Management System (AMS) Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner.
- Primary Outcome Measures
Name Time Method Biometric Data Associations to Arrhythmias 30 days MCT Data Sets
Biometric Data Associations to Subject-Reported Symptoms 30 days MCT Data Sets
Biometric Data Associations to Subject Wellness 30 days MCT Data Sets
- Secondary Outcome Measures
Name Time Method Clinician Use of Biometric Data Associations to Subject-Reported Symptoms 30 days Clinical Case Report Forms
Clinician Use of Biometric Data Associations to Arrhythmias 30 days Clinical Case Report Forms
Clinician Use of Biometric Data Associations to Wellness Status of Subject 30 days Clinical Case Report Forms
Trial Locations
- Locations (20)
Comprehensive Cardiovascular Medical Group
🇺🇸Bakersfield, California, United States
Cardiovascular Innovation and Research Center
🇺🇸Long Beach, California, United States
Heartbeat Cardiovascular Medical Group
🇺🇸Los Angeles, California, United States
Interventional Cardiology Group
🇺🇸West Hills, California, United States
Flagler Hospital/Flagler Health
🇺🇸Jacksonville, Florida, United States
Cardiovascular Institute of Central Florida
🇺🇸Ocala, Florida, United States
First Coast Heart and Vascular Center
🇺🇸Saint Augustine, Florida, United States
Cardiovascular Research of Northwest Indiana
🇺🇸Munster, Indiana, United States
Cardiovascular Research of Northwest
🇺🇸Munster, Indiana, United States
Trinity Medical
🇺🇸Cheektowaga, New York, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
ClinicalTex Research LLC d/b/a PharmaTex Research
🇺🇸Amarillo, Texas, United States
Texas Cardiology Associates of Houston
🇺🇸Kingwood, Texas, United States
Heart Rhythm Specialists
🇺🇸McKinney, Texas, United States
CardioVoyage
🇺🇸McKinney, Texas, United States
Orion Medical Research
🇺🇸Pasadena, Texas, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Daniel W. Gottlieb, MD, PS
🇺🇸Burien, Washington, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States