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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Arrhythmia Management System (AMS)

Detailed Description

1. 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.
2. Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ocala, Florida, United States, 34471
      • Cardiovascular Institute of Central Florida
    • Saint Augustine, Florida, United States, 32086
      • First Coast Heart & Vascular Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Texas
    • Amarillo, Texas, United States, 79109
      • Pharmatex Research
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • McKinney, Texas, United States, 75071
      • Cardiovoyage
  • Washington
    • Burien, Washington, United States, 98166
      • Dr. Daniel W. Gottlieb
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Medical Center EP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who completed the MAPS study with a reported medication change based wholly or in part on biometric information.

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MAPS Study Patients with Medication Change Reported; No intervention will be administered. This is a retrospective study of the patients who participating in the MAPS Protocol 90D0234 completed in 2021. Patients who had a medication change reported in that study are the focus of this study MAPS II 90D0255.	Device: Arrhythmia Management System (AMS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between Arrhythmia Biometric and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject-Reported Symptom Biometric and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject Wellness Biometric and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject Adverse Event and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject Status and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject Hospital Events and Medication Change	Clinical Case Report Form	1 Day
Association Between Subject Clinical Events and Medication Change	Clinical Case Report Form	1 Day

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Chair: Steven Ringquist, Zoll Services LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 90D0255

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