Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.
• NYHA Class III-IV
• NYHA Class II HF with one or more of the following:
‣ Chronic Kidney Disease (eGFR\<60)
⁃ 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/m 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)