Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients with Chronic Heart Failure
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients with Chronic Heart Failure
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Clinical Trial Information
Trial Contact: Hernandez-Pagan, Gloryvee; Cox, Caitlin L; Ngo, George M.; Soto, William
Trial Phone: 321-841-3686 ; 321-841-1505 ; 3218439657 ; 321-343-1179
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IRB No: 22.198.09
Protocol Abbrev: ANALOG DEVICES
Principal Investigator: Shahid Qamar, MD
Age Group: Adult
Treatment: The CPM system consists of a wearable device that measures a number of non-invasive physiological parameters to track the heart and lung condition, a base station, a provider web app for reviewing patient’s data, and a mobile app to baseline and enroll patients into the system.
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Objective
Primary: To support the hypothesis (pilot data) that the use of the CPM system reduces the rate of HF related events (defined later) and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction.
Secondary: To assess the deployment and day to day interoperability of the ADI CardioPulmonary Management System within existing clinical workflows. -
Key Eligibility
>18 with HF regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:
· NYHA Class III HF
· NYHA Class IV HF
