Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)

Status unconfirmed · Not applicable

Conditions studied: Heart Failure

In brief

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 facts

Study ID

NCT05980585

Run by

Analog Device, Inc.

People needed

50

Starts

2022-04-20

Expected to finish

2025-06-01

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Under age 60
• End Stage Renal Disease
• Patients with severe COPD (GOLD stage III or IV)
• Limited mobility preventing application of device
• Cognitive impairments that would limit the application and proper use of the device
• Skin allergies or skin sensitivities to silicone-based adhesives
• Pregnancy
• Skin breakdown on the left chest or breast area
• Not willing to shave chest hair if needed to apply device
• No cellular coverage (Patient's Home)

Where it is running

• Baptist Health — Jacksonville Beach, Florida, United States

Full record on ClinicalTrials.gov

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