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

Description

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.

Conditions

Heart Failure

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Palm Springs

Desert Oasis Healthcare, Palm Springs, California, United States, 92262

Miami

Baptist Health South Florida, Miami, Florida, United States, 33173

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Greensboro

Cone Health, Greensboro, North Carolina, United States, 27401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * NYHA Class III HF
  • * NYHA Class IV HF
  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Analog Device, Inc.,

Study Record Dates

2025-06-01