Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

NCT ID: NCT04754204

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

585 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients indicated for Mobile Cardiac Telemetry Monitoring

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

Arrhythmia Management System (AMS)

Intervention Type DEVICE

AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

Interventions

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Arrhythmia Management System (AMS)

AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramu Perumal, PhD

Role: STUDY_CHAIR

Zoll Services LLC

Locations

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Comprehensive Cardiovascular Medical Group

Bakersfield, California, United States

Site Status

Cardiovascular Innovation and Research Center

Long Beach, California, United States

Site Status

Heartbeat Cardiovascular Medical Group

Los Angeles, California, United States

Site Status

Interventional Cardiology Group

West Hills, California, United States

Site Status

Flagler Hospital/Flagler Health

Jacksonville, Florida, United States

Site Status

Cardiovascular Institute of Central Florida

Ocala, Florida, United States

Site Status

First Coast Heart and Vascular Center

Saint Augustine, Florida, United States

Site Status

Cardiovascular Research of Northwest Indiana

Munster, Indiana, United States

Site Status

Cardiovascular Research of Northwest

Munster, Indiana, United States

Site Status

Jackson Heart Clinic

Jackson, Mississippi, United States

Site Status

Trinity Medical

Cheektowaga, New York, United States

Site Status

PMG Research of Wilmington

Wilmington, North Carolina, United States

Site Status

Erlanger Health System

Chattanooga, Tennessee, United States

Site Status

ClinicalTex Research LLC d/b/a PharmaTex Research

Amarillo, Texas, United States

Site Status

Texas Cardiology Associates of Houston

Kingwood, Texas, United States

Site Status

Heart Rhythm Specialists

McKinney, Texas, United States

Site Status

CardioVoyage

McKinney, Texas, United States

Site Status

Orion Medical Research

Pasadena, Texas, United States

Site Status

Daniel W. Gottlieb, MD, PS

Burien, Washington, United States

Site Status

St. Mary's Medical Center

Huntington, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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90D0234

Identifier Type: -

Identifier Source: org_study_id

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