Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

Cardiac Arrhythmia Clinical Trial

— MAPS  

Official title:

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754204
• Other study ID #: 90D0234
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Arrhythmia Management System (AMS)
AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

Locations

Country	Name	City	State
United States	ClinicalTex Research LLC d/b/a PharmaTex Research	Amarillo	Texas
United States	Comprehensive Cardiovascular Medical Group	Bakersfield	California
United States	Daniel W. Gottlieb, MD, PS	Burien	Washington
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Trinity Medical	Cheektowaga	New York
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Flagler Hospital/Flagler Health	Jacksonville	Florida
United States	Texas Cardiology Associates of Houston	Kingwood	Texas
United States	Cardiovascular Innovation and Research Center	Long Beach	California
United States	Heartbeat Cardiovascular Medical Group	Los Angeles	California
United States	CardioVoyage	McKinney	Texas
United States	Heart Rhythm Specialists	McKinney	Texas
United States	Cardiovascular Research of Northwest	Munster	Indiana
United States	Cardiovascular Research of Northwest Indiana	Munster	Indiana
United States	Cardiovascular Institute of Central Florida	Ocala	Florida
United States	Orion Medical Research	Pasadena	Texas
United States	First Coast Heart and Vascular Center	Saint Augustine	Florida
United States	Interventional Cardiology Group	West Hills	California
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biometric Data Associations to Arrhythmias	MCT Data Sets	30 days
Primary	Biometric Data Associations to Subject-Reported Symptoms	MCT Data Sets	30 days
Primary	Biometric Data Associations to Subject Wellness	MCT Data Sets	30 days
Secondary	Clinician Use of Biometric Data Associations to Arrhythmias	Clinical Case Report Forms	30 days
Secondary	Clinician Use of Biometric Data Associations to Subject-Reported Symptoms	Clinical Case Report Forms	30 days
Secondary	Clinician Use of Biometric Data Associations to Wellness Status of Subject	Clinical Case Report Forms	30 days