Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04754204

Acronym

MAPS

Enrollment

585

Registered

2021-02-15

Start date

2020-12-15

Completion date

2021-12-15

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

cardiac, arrhythmia

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.

Interventions

DEVICEArrhythmia Management System (AMS)

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Clinician Use of Biometric Data Associations to Arrhythmias	30 days	Clinical Case Report Forms
Clinician Use of Biometric Data Associations to Subject-Reported Symptoms	30 days	Clinical Case Report Forms
Clinician Use of Biometric Data Associations to Wellness Status of Subject	30 days	Clinical Case Report Forms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026