Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Analog Device, Inc.
You may qualify if…
- ✓ 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+
You may not qualify if…
- ✕ 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)
Where it's recruiting
Palm Springs
Miami · Orlando
Springfield
Omaha
Greensboro
Greenville
Source: ClinicalTrials.gov · NCT05650541 · last updated 2026-01-30