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

Cardiac Arrhythmia Clinical Trial

— MAPS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505136
• Other study ID #: 90D0255
• Status: Completed
• Start date: August 30, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: June 2023
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
United States	PharmaTex Research	Amarillo	Texas
United States	Dr. Daniel W. Gottlieb	Burien	Washington
United States	St. Mary's Medical Center EP	Huntington	West Virginia
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Texas Cardiology Associates of Houston	Kingwood	Texas
United States	CardioVoyage	McKinney	Texas
United States	Cardiovascular Institute of Central Florida	Ocala	Florida
United States	First Coast Heart & Vascular Center	Saint Augustine	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association Between Arrhythmia Biometric and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject-Reported Symptom Biometric and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject Wellness Biometric and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject Adverse Event and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject Status and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject Hospital Events and Medication Change	Clinical Case Report Form	1 Day
Primary	Association Between Subject Clinical Events and Medication Change	Clinical Case Report Form	1 Day