Status:
RECRUITING
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure ( BETA )
Lead Sponsor:
Analog Device, Inc.
Collaborating Sponsors:
Orlando Health, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 m...
Detailed 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 a...
Eligibility Criteria
Inclusion
- Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:
- NYHA Class III-IV
- 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/m 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
- Under 18 years of age
- Patients with severe COPD (GOLD stage III or IV)
- Limited mobility preventing application of device
- Cognitive impairments that would limit the application and proper use of the device
- Skin allergies or skin sensitivities to silicone-based adhesives
- Pregnancy
- Skin breakdown on the left chest or breast area
- Not willing to shave chest hair if needed to apply device
- Patients on chronic ionotropic therapy
- 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)
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06007131
Start Date
December 15 2023
End Date
November 1 2025
Last Update
February 23 2024
Active Locations (1)
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1
Orlando Health
Orlando, Florida, United States, 32806