RecruitingNot ApplicableNCT05650541

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

Sponsor

Analog Device, Inc.

Enrollment

1,200 participants

Start Date

Sep 22, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria11

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

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.