Clincosm LogoSign in Get a demo

MAPS: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04754204
Collaborator
(none)
585
Enrollment
20
Locations
12
Actual Duration (Months)
29.3
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Arrhythmia Management System (AMS)

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 Design

Study Type:
Observational
Actual Enrollment :
585 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
Actual Study Start Date :
Dec 15, 2020
Actual Primary Completion Date :
Dec 15, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients indicated for Mobile Cardiac Telemetry Monitoring

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

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

Outcome Measures

Primary Outcome Measures

  1. Biometric Data Associations to Arrhythmias [30 days]

    MCT Data Sets

  2. Biometric Data Associations to Subject-Reported Symptoms [30 days]

    MCT Data Sets

  3. Biometric Data Associations to Subject Wellness [30 days]

    MCT Data Sets

Secondary Outcome Measures

  1. Clinician Use of Biometric Data Associations to Arrhythmias [30 days]

    Clinical Case Report Forms

  2. Clinician Use of Biometric Data Associations to Subject-Reported Symptoms [30 days]

    Clinical Case Report Forms

  3. Clinician Use of Biometric Data Associations to Wellness Status of Subject [30 days]

    Clinical Case Report Forms

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Flagler Hospital/Flagler Health Jacksonville Florida United States 32086
6 Cardiovascular Institute of Central Florida Ocala Florida United States 34476
7 First Coast Heart and Vascular Center Saint Augustine Florida United States 32086
8 Cardiovascular Research of Northwest Indiana Munster Indiana United States 46321
9 Cardiovascular Research of Northwest Munster Indiana United States 46321
10 Jackson Heart Clinic Jackson Mississippi United States 39216
11 Trinity Medical Cheektowaga New York United States 14227
12 PMG Research of Wilmington Wilmington North Carolina United States 28401
13 Erlanger Health System Chattanooga Tennessee United States 37403
14 ClinicalTex Research LLC d/b/a PharmaTex Research Amarillo Texas United States 79109
15 Texas Cardiology Associates of Houston Kingwood Texas United States 77339
16 Heart Rhythm Specialists McKinney Texas United States 75070
17 CardioVoyage McKinney Texas United States 75071
18 Orion Medical Research Pasadena Texas United States 77505
19 Daniel W. Gottlieb, MD, PS Burien Washington United States 98166
20 St. Mary's Medical Center Huntington West Virginia United States 25702

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

  • Study Chair: Ramu Perumal, PhD, Zoll Services LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT04754204
Other Study ID Numbers:
  • 90D0234
First Posted:
Feb 15, 2021
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Zoll Medical Corporation
cardiac
arrhythmia
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Feb 9, 2022