Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Age

• 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

• 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)