NCT05650541 · Analog Device, Inc.
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
(BETA)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Palm Springs, California
- Miami, Florida
- Orlando, Florida
- Springfield, Massachusetts
- Omaha, Nebraska
- Greensboro, North Carolina
- Greenville, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations