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

ZOLL Medical

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Device: Arrhythmia Management System (AMS)

Study type: Observational

Funder types: Industry

Identifiers

NCT05505136

90D0255

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

62 participants in 1 patient group

MAPS Study Patients with Medication Change Reported

Description:

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.

Treatment:

Device: Arrhythmia Management System (AMS)