Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

Completed

• Conditions: Cardiac Arrhythmia

• 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.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biometric Data Associations to Subject-Reported Symptoms	30 days	MCT Data Sets
Biometric Data Associations to Subject Wellness	30 days	MCT Data Sets
Biometric Data Associations to Arrhythmias	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

Jackson Heart Clinic; 🇺🇸 Jackson, Mississippi, United States

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