Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes
- Conditions
- Cardiac Arrhythmia
- Interventions
- Device: Arrhythmia Management System (AMS)
- Registration Number
- NCT05505136
- Lead Sponsor
- Zoll Medical Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.
- Those patients from the MAPS study that did not have medication changes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MAPS Study Patients with Medication Change Reported Arrhythmia Management System (AMS) 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.
- Primary Outcome Measures
Name Time Method Association Between Subject Wellness Biometric and Medication Change 1 Day Clinical Case Report Form
Association Between Subject Status and Medication Change 1 Day Clinical Case Report Form
Association Between Arrhythmia Biometric and Medication Change 1 Day Clinical Case Report Form
Association Between Subject-Reported Symptom Biometric and Medication Change 1 Day Clinical Case Report Form
Association Between Subject Adverse Event and Medication Change 1 Day Clinical Case Report Form
Association Between Subject Hospital Events and Medication Change 1 Day Clinical Case Report Form
Association Between Subject Clinical Events and Medication Change 1 Day Clinical Case Report Form
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
St. Mary's Medical Center EP
🇺🇸Huntington, West Virginia, United States
Cardiovascular Institute of Central Florida
🇺🇸Ocala, Florida, United States
PharmaTex Research
🇺🇸Amarillo, Texas, United States
First Coast Heart & Vascular Center
🇺🇸Saint Augustine, Florida, United States
CardioVoyage
🇺🇸McKinney, Texas, United States
Dr. Daniel W. Gottlieb
🇺🇸Burien, Washington, United States
Texas Cardiology Associates of Houston
🇺🇸Kingwood, Texas, United States