Tests a CardioPulmonary Management device in adults with chronic heart failure
Compares a monitoring device with usual care in adults with chronic heart failure.
Plain-language title generated from the registry record
Registry title: Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Key facts
- Where
- Greensboro, Greenville, Miami, Omaha, Orlando, Palm Springs, and Springfield, United StatesSee the 7 sites
Where in United States
- Cone HealthGreensboro, United StatesNo longer taking part
- Prisma HealthGreenville, United StatesNo longer taking part
- Baptist Health South FloridaMiami, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- Orlando HealthOrlando, United StatesTaking people
- Desert Oasis HealthcarePalm Springs, United StatesNo longer taking part
- Baystate Medical CenterSpringfield, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Analog Device, Inc.
- Trial code
- NCT05650541
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
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.
Inclusion: Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:; NYHA Class III HF; NYHA Class IV HF; OR; NYHA Class II HF with one or more of the following:; Chronic Kidney Disease (eGFR<60 within the past 6 months); HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP > 200 pg/ml* for patients not in AF or > 600 pg/ml* for patients in AF on screening ECG+; NT-proBNP > 300 pg/ml* for patients not in AF or > 900 pg/ml* for patients in AF on the screening visit ECG+; Chronic obstructive pulmonary disease (COPD).
Exclusion: Under 18 years of age; Patients with severe COPD (GOLD stage III or IV); Limited mobility preventing application of device or no caregiver to assist; Cognitive impairments that would limit the application and proper use of the device; Skin allergies or skin sensitivities to silicone-based adhesives; Pregnancy (method of assessment at the discretion of the PI); Not willing to shave chest hair if needed to apply device; Patients on chronic IV ionotropic therapy - (Milrinone, Dobutamine, and Dopamine); Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator; No cellular coverage (Patient's Home)**; Skin breakdown on the left chest or breast area.