Cardiac Arrhythmia
Conditions
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.
Interventions
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.
Sponsors
Zoll Medical Corporation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Wellness 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 Status 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 |
Countries
United States
Outcome results
None listed