Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Part of paid clinical trials in Palm Springs, California.

Sponsor
Analog Device, Inc.
Study ID
NCT05650541
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CardioPumlonary Management System — DEVICE
    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.

Study Details

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 Dates

Start date
Sep 22, 2023
Status verified
Jan 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Study Group
    The study group will use the CPM device daily for 6 months (beginning at visit 1 and ending at visit 2). The ADI triaging team will monitor the CPM device data and call the patient as indicated by the data. The ADI care team will then forward the device data and patient symptomology collected to the patient's care team where that team will device if intervention is necessary. The patient's care team will also have access to view device data at any time using the CPM website.
  • No Intervention: Control Group
    The control group will not receive a device and will continue their normal standard of care.

Primary Outcome Measure

Admission Rate [ Time Frame: 7 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Desert Oasis HealthcarePalm SpringsCalifornia92262-
Baptist Health South FloridaMiamiFlorida33173
Anabel Elizechea Gispert, RN, BSN, MSN
[email protected]
786-595-8073
Jonathan Fialkow, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthOrlandoFlorida32806
Caitlin Cox, RN, BSN
[email protected]
321-841-1505
Shahid Qamar, MD (PRINCIPAL_INVESTIGATOR)
Baystate Medical CenterSpringfieldMassachusetts01199-
University of Nebraska Medical CenterOmahaNebraska68189-
Cone HealthGreensboroNorth Carolina27401-
Prisma HealthGreenvilleSouth Carolina29601-

Find similar trials in Palm Springs, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Desert Oasis Healthcare· Palm Springs, CABaptist Health South Florida· Miami, FLOrlando Health· Orlando, FLBaystate Medical Center· Springfield, MAUniversity of Nebraska Medical Center· Omaha, NECone Health· Greensboro, NC

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