Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Analog Device, Inc.
Summary
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.
Description
This study is meant primarily to determine the clinical and financial efficacy of the CPM system in reducing HF events and their associated cost. Although patients will use an investigational device as part of this pilot, the device is passive and of minimal risk to the patient. No treatment changes will be decided on the CPM data solely. All CPM data will be confirmed with a symptomology assessment and the patient's care provider will make the final determination whether a change of treatment is appropriate or not. There will be two groups, the study cohort and the control cohort. After info…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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…
Interventions
- DeviceCardioPumlonary Management System
The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.
Locations (7)
- Desert Oasis HealthcarePalm Springs, California
- Baptist Health South FloridaMiami, Florida
- Orlando HealthOrlando, Florida
- Baystate Medical CenterSpringfield, Massachusetts
- University of Nebraska Medical CenterOmaha, Nebraska
- Cone HealthGreensboro, North Carolina