Actively Recruiting
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Led by Analog Device, Inc. · Updated on 2026-01-30
1200
Participants Needed
7
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart failure patients of any ejection fraction (HFpEF or HFrEF) with NYHA Class III or IV heart failure
- Patients with NYHA Class II heart failure plus one or more of the following: chronic kidney disease (eGFR <60 within past 6 months), heart failure hospitalization within 9 months prior to screening, elevated NT-proBNP levels as specified, or chronic obstructive pulmonary disease (COPD)
You will not qualify if you...
- Under 18 years of age
- Severe COPD (GOLD stage III or IV)
- Limited mobility preventing device application or no caregiver to assist
- Cognitive impairments limiting device use
- Skin allergies or sensitivities to silicone-based adhesives
- Pregnancy
- Unwillingness to shave chest hair if needed for device application
- Use of chronic intravenous ionotropic therapy (Milrinone, Dobutamine, Dopamine)
- Any condition limiting survival to less than one year as assessed by investigator
- No cellular coverage at patient's home
- Skin breakdown on the left chest or breast area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Desert Oasis Healthcare
Palm Springs, California, United States, 92262
Completed
2
Baptist Health South Florida
Miami, Florida, United States, 33173
Actively Recruiting
3
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
4
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Active, Not Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68189
Active, Not Recruiting
6
Cone Health
Greensboro, North Carolina, United States, 27401
Completed
7
Prisma Health
Greenville, South Carolina, United States, 29601
Completed
Research Team
E
Emily Wycallis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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