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NCT05957172 · Status: WITHDRAWN · Type: OBSERVATIONAL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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957172 on ClinicalTrials.gov