Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation
NCT05957172 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2023-07-24
Summary
Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF \> 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.
Conditions
- Heart Attack
- Cardiac Event
- Cardiac Disease
- Cardiac Infarct
- NSTEMI
- STEMI
Interventions
- DEVICE
-
ZOLL Arrhythmia Management System
AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity, and body posture (biometric data)
Sponsors & Collaborators
-
Zoll Medical Corporation
lead INDUSTRY
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2023-07-31
- Completion
- 2023-10-31
- FDA Device
- Yes
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