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Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)
Sponsor: Analog Device, Inc.
Summary
This study is meant primarily to assess the deployment of the ADI CPM System in a clinical setting and determine interoperability of the CPM System within existing care pathways for patients with CHF. In this initial study the CPM System will not be used to determine or support clinical decision making however post deployment the clinical study team will review patient HF events and changes in treatment during the course of the deployment and compare to the data generated by the CPM System during the study to determine the accuracy of the patient generated data as a basis for designing a more comprehensive "interventional study" to determine clinical and financial efficacy of the CPM System.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
2
Start Date
2022-04-20
Completion Date
2024-06-24
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
CPM Device
Daily use of the CPM wearable device
Locations (1)
Baptist Health
Jacksonville Beach, Florida, United States