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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnalog Device, Inc.

About this trial

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 criteria

Qualifiers

NYHA Class III HF

NYHA Class IV HF

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+

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CardioPumlonary Management System

Treatment groups

1,200 Participants
are divided into 2 treatment groups

Sponsors and collaborators