Status:
NOT_YET_RECRUITING
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure (Beta Study)
Lead Sponsor:
Analog Device, 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 CardioPumonary Management (CPM) system reduces the rate of heart failure (HF) related events and the re...
Detailed Description
This study is meant primarily to determine the clinical and financial efficacy of the CardioPulmonary Management (CPM) system in reducing heart failure (HF) events and their associated cost. Although ...
Eligibility Criteria
Inclusion
- Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preserved ejection fraction) or HFrEF (heart failure reserved ejection fraction), with one or more of the following:
- New York Heart Association (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) (Estimated Glomerular Filtration Rate)
- HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP (N-terminal pro b-type natriuretic peptide) \> 200 pg/ml for patients not in atrial fibrillation (AF) or \> 600 pg/m for patients in AF on screening ECG (electrocardiogram)
- 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 :
June 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06078267
Start Date
June 12 2024
End Date
July 1 2026
Last Update
February 23 2024
Active Locations (1)
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1
Baptist Health South Florida
Miami, Florida, United States, 33173