About this trial
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.
Eligibility criteria
Qualifiers
NYHA Class III HF
NYHA Class IV HF
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+
Disqualifiers
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
Trial design
Treatments tested in this trial
- CardioPumlonary Management System