Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Zoll Medical Corporation
- Enrollment
- 62
- Locations
- 8
- Primary Endpoint
- Association Between Subject Wellness Biometric and Medication Change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Association Between Subject Wellness Biometric and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Subject Status and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Arrhythmia Biometric and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Subject-Reported Symptom Biometric and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Subject Adverse Event and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Subject Hospital Events and Medication Change
Time Frame: 1 Day
Clinical Case Report Form
Association Between Subject Clinical Events and Medication Change
Time Frame: 1 Day
Clinical Case Report Form