Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Recruiting · NCT05650541 · Interventional (participants receive a specific treatment) · Lead sponsor: Analog Device, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CardioPumlonary Management System
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 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 criteria
- 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
Where it is running
7 locations listed across 6 US states.
- 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