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

NCT05650541 | Recruiting FDA Device

• 1 other identifier: BETA-3.0
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 7

Brief Summary

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

Heart Failure

Outcome Measures

Primary Outcomes (6)

• Admission Rate

  Admission rate for HF and HF related events in the study group vs. the institution's averages (and/or control group)

  7 months

• Readmission Rate

  Readmission rate for HF and HF related events in study group vs. the institution's average (and/or control group)

  7 months

• Healthcare Utilization

  Healthcare utilization for HF related events, including number of practice visits, ER visits, outpatient visits, skilled nursing facility (SNF) days and Hospital Admissions

  7 months

• Patient satisfaction

  Patient satisfaction obtained through surveys

  6 months

• Cost of care

  Total cost per capita for HF related care

  7 months (during study) and 12 months prior to the study

• Quality of care

  Impact on quality of care

  6 months

Secondary Outcomes (1)

• Usability

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

The study group will use the CPM device daily for 6 months (beginning at visit 1 and ending at visit 2). The ADI triaging team will monitor the CPM device data and call the patient as indicated by the data. The ADI care team will then forward the device data and patient symptomology collected to the patient's care team where that team will device if intervention is necessary. The patient's care team will also have access to view device data at any time using the CPM website.

Device: CardioPumlonary Management System

Control Group

NO INTERVENTION

The control group will not receive a device and will continue their normal standard of care.

Interventions

CardioPumlonary Management System DEVICE

The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Analog Device, Inc.: lead

Study Sites (7)

Desert Oasis Healthcare

Palm Springs, California, 92262, United States

COMPLETED

Baptist Health South Florida

Miami, Florida, 33173, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

ACTIVE NOT RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68189, United States

ACTIVE NOT RECRUITING

Cone Health

Greensboro, North Carolina, 27401, United States

COMPLETED

Prisma Health

Greenville, South Carolina, 29601, United States

COMPLETED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Emily Wycallis

CONTACT

978-435-1644; emily.wycallis@analog.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is a study group that uses the device \& the data is monitored and sent to the physician. The second group is a control group that will not use the device and will continue with normal standard of care.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 14, 2022
• Study Start: September 22, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)