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

• Sponsor: Zoll Medical Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05505136
• Collaborator: (none)
• Enrollment: 80
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	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 Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Association Between Arrhythmia Biometric and Medication Change [1 Day]

   Clinical Case Report Form

2. Association Between Subject-Reported Symptom Biometric and Medication Change [1 Day]

   Clinical Case Report Form

3. Association Between Subject Wellness Biometric and Medication Change [1 Day]

   Clinical Case Report Form

4. Association Between Subject Adverse Event and Medication Change [1 Day]

   Clinical Case Report Form

5. Association Between Subject Status and Medication Change [1 Day]

   Clinical Case Report Form

6. Association Between Subject Hospital Events and Medication Change [1 Day]

   Clinical Case Report Form

7. Association Between Subject Clinical Events and Medication Change [1 Day]

   Clinical Case Report Form

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zoll Medical Corporation

Investigators

• Study Chair: Steven Ringquist, Zoll Services LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zoll Medical Corporation
• ClinicalTrials.gov Identifier: NCT05505136
• Other Study ID Numbers: 90D0255
• First Posted: Aug 17, 2022
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 17, 2022