Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Recruiting
N/AInterventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,200 (estimated)
Sponsor
Analog Device, Inc. · Other
Who this trial is looking for
This trial is looking for patients with chronic heart failure who may benefit from a new management system. Participants will use the Sensinel CPM system to help monitor and manage their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have chronic heart failure
I have NYHA Class II, III, or IV heart failure
I have chronic kidney disease
I have been hospitalized for heart failure in the last 9 months
I have chronic obstructive pulmonary disease
You may not be able to join if
I am under 18 years old
I have severe chronic obstructive pulmonary disease
I have limited mobility that prevents using the device
I have cognitive impairments that affect my ability to use the device
I am pregnant
I cannot shave my chest hair if needed for the device
I receive chronic IV ionotropic therapy
I have skin breakdown on the left chest or breast area
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 sys…
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.
Trial Locations
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Status
Eligibility Criteria
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 hospita…
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
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