Who is eligible for clinical trial NCT05650541?

Participants must meet protocol criteria for Heart Failure. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05650541 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-17

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure (NCT05650541)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Analog Device, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).

Location: Desert Oasis Healthcare — Palm Springs, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

Desert Oasis Healthcare — Palm Springs, California
Baptist Health South Florida — Miami, Florida
Orlando Health — Orlando, Florida
Baystate Medical Center — Springfield, Massachusetts
University of Nebraska Medical Center — Omaha, Nebraska
Cone Health — Greensboro, North Carolina
Prisma Health — Greenville, South Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗