Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients (MAPS)
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| ClinicalTrials.gov Identifier: NCT04754204 |
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Recruitment Status :
Completed
First Posted : February 15, 2021
Last Update Posted : February 9, 2022
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Sponsor:
Zoll Medical Corporation
Information provided by (Responsible Party):
Zoll Medical Corporation
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Brief Summary:
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
| Condition or disease | Intervention/treatment |
|---|---|
| Cardiac Arrhythmia | Device: Arrhythmia Management System (AMS) |
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 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 : | December 15, 2020 |
| Actual Primary Completion Date : | December 15, 2021 |
| Actual Study Completion Date : | December 15, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Device: Arrhythmia Management System (AMS)
AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture. |
Primary Outcome Measures :
- Biometric Data Associations to Arrhythmias [ Time Frame: 30 days ]MCT Data Sets
- Biometric Data Associations to Subject-Reported Symptoms [ Time Frame: 30 days ]MCT Data Sets
- Biometric Data Associations to Subject Wellness [ Time Frame: 30 days ]MCT Data Sets
Secondary Outcome Measures :
- Clinician Use of Biometric Data Associations to Arrhythmias [ Time Frame: 30 days ]Clinical Case Report Forms
- Clinician Use of Biometric Data Associations to Subject-Reported Symptoms [ Time Frame: 30 days ]Clinical Case Report Forms
- Clinician Use of Biometric Data Associations to Wellness Status of Subject [ Time Frame: 30 days ]Clinical Case Report Forms
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult subjects, 21 years or older who:
- Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias
- Are without any cardiac implantable electronic devices, including loop recorders
- Are without wearable cardioverter defibrillator
- Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
- Are not currently hospitalized
- Do not have any skin condition that would prevent them from wearing the AMS device
- Are not non-ambulatory
- Are not reporting to be pregnant
- Are not participating in another clinical study
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754204
Locations
Show 20 study locations
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
| Study Chair: | Ramu Perumal, PhD | Zoll Services LLC |
| Responsible Party: | Zoll Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT04754204 |
| Other Study ID Numbers: |
90D0234 |
| First Posted: | February 15, 2021 Key Record Dates |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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cardiac arrhythmia |
Additional relevant MeSH terms:
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Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |