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

RecruitingNA

Sponsor: Analog Device, Inc.

Conditions: Heart Failure

Interventions: CardioPumlonary Management System

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 in AF on the screening visit ECG+
* Chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

* 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

Locations (7)

Palm Springs, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Springfield, Massachusetts, United States
Omaha, Nebraska, United States
Greensboro, North Carolina, United States
Greenville, South Carolina, United States