NCT05505136

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-03-01
• Completion: 2023-05-15
• First posted: 2022-08-17
• Last updated: 2023-06-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study