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Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Sponsor: Analog Device, Inc.
Summary
The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2023-09-22
Completion Date
2026-06-01
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
CardioPumlonary Management System
The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.
Locations (7)
Desert Oasis Healthcare
Palm Springs, California, United States
Baptist Health South Florida
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cone Health
Greensboro, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States