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

February 8, 2022 updated by: Zoll Medical Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Cardiovascular Medical Group
      • Long Beach, California, United States, 90813
        • Cardiovascular Innovation and Research Center
      • Los Angeles, California, United States, 90027
        • Heartbeat Cardiovascular Medical Group
      • West Hills, California, United States, 91307
        • Interventional Cardiology Group
    • Florida
      • Jacksonville, Florida, United States, 32086
        • Flagler Hospital/Flagler Health
      • Ocala, Florida, United States, 34476
        • Cardiovascular Institute of Central Florida
      • Saint Augustine, Florida, United States, 32086
        • First Coast Heart and Vascular Center
    • Indiana
      • Munster, Indiana, United States, 46321
        • Cardiovascular Research of Northwest Indiana
      • Munster, Indiana, United States, 46321
        • Cardiovascular Research of Northwest
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • New York
      • Cheektowaga, New York, United States, 14227
        • Trinity Medical
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System
    • Texas
      • Amarillo, Texas, United States, 79109
        • ClinicalTex Research LLC d/b/a PharmaTex Research
      • Kingwood, Texas, United States, 77339
        • Texas Cardiology Associates of Houston
      • McKinney, Texas, United States, 75070
        • Heart Rhythm Specialists
      • McKinney, Texas, United States, 75071
        • CardioVoyage
      • Pasadena, Texas, United States, 77505
        • Orion Medical Research
    • Washington
      • Burien, Washington, United States, 98166
        • Daniel W. Gottlieb, Md, Ps
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects, 21 years or older who:

  1. Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias
  2. Are without any cardiac implantable electronic devices, including loop recorders
  3. Are without wearable cardioverter defibrillator
  4. Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
  5. Are not currently hospitalized
  6. Do not have any skin condition that would prevent them from wearing the AMS device
  7. Are not non-ambulatory
  8. Are not reporting to be pregnant
  9. Are not participating in another clinical study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biometric Data Associations to Arrhythmias
Time Frame: 30 days
MCT Data Sets
30 days
Biometric Data Associations to Subject-Reported Symptoms
Time Frame: 30 days
MCT Data Sets
30 days
Biometric Data Associations to Subject Wellness
Time Frame: 30 days
MCT Data Sets
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinician Use of Biometric Data Associations to Arrhythmias
Time Frame: 30 days
Clinical Case Report Forms
30 days
Clinician Use of Biometric Data Associations to Subject-Reported Symptoms
Time Frame: 30 days
Clinical Case Report Forms
30 days
Clinician Use of Biometric Data Associations to Wellness Status of Subject
Time Frame: 30 days
Clinical Case Report Forms
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zoll Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ramu Perumal, PhD, Zoll Services LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90D0234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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