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To determine the associations among biometric data and previously reported medication changes in the original MAPS study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAPS Study Patients with Medication Change Reported | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arrhythmia Management System (AMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Arrhythmia Biometric and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject-Reported Symptom Biometric and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject Wellness Biometric and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject Adverse Event and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject Status and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject Hospital Events and Medication Change | Clinical Case Report Form | 1 Day |
| Association Between Subject Clinical Events and Medication Change | Clinical Case Report Form | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects who completed the MAPS study with a reported medication change based wholly or in part on biometric information.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Ringquist | Zoll Services LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of Central Florida | Ocala | Florida | 34471 | United States | ||
| First Coast Heart & Vascular Center |
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| Saint Augustine |
| Florida |
| 32086 |
| United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| PharmaTex Research | Amarillo | Texas | 79109 | United States |
| Texas Cardiology Associates of Houston | Kingwood | Texas | 77339 | United States |
| CardioVoyage | McKinney | Texas | 75071 | United States |
| Dr. Daniel W. Gottlieb | Burien | Washington | 98166 | United States |
| St. Mary's Medical Center EP | Huntington | West Virginia | 25702 | United States |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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