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Completed

NCT Number: NCT05505136

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes

To determine the associations among biometric data and previously reported medication changes in the original MAPS study

Completed

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Institute of Central Florida, Ocala, Florida, United States

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About this study

  • Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision.
  • Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.

Exclusion criteria

  • Those patients from the MAPS study that did not have medication changes.

Treatment and study plan

Arrhythmia Management System (AMS)

Device

Retrospective collection of data related to subjects who participated in the MAPS 90D0234 study and had a medication change reported will wearing the AMS device.

Primary outcomes

  1. Association Between Arrhythmia Biometric and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  2. Association Between Subject-Reported Symptom Biometric and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  3. Association Between Subject Wellness Biometric and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  4. Association Between Subject Adverse Event and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  5. Association Between Subject Status and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  6. Association Between Subject Hospital Events and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

  7. Association Between Subject Clinical Events and Medication Change

    Time frame: 1 Day

    Clinical Case Report Form

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based

Acronym: MAPS II

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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