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 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 CPM system against those who are not. This can either be done using institutions averages, if available, or through a control group.
⁃ 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)