Recruiting
Phase 2
Phase 3

CardioPulmonary Monitoring

Sponsor:

Analog Device, Inc.

Code:

NCT05978518

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPM Device + Monitoring

CPM Device

Study Details

Brief summary:

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the 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 CPM system \& have their data reviewed by a physician against those who are using the CPM system and not having their data reviewed.

Conditions

Heart Failure

Study ID

NCT05978518

Start date

Jul 13, 2023

Status verified date

Feb, 2024

Completion date

Dec 20, 2025

Anticipated

Primary completion date

Jun 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:

  • NYHA Class III-IV
  • 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/m 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
  • Cognitive impairments that would limit the application and proper use of the device
  • Skin allergies or skin sensitivities to silicone-based adhesives
  • Pregnancy
  • Skin breakdown on the left chest or breast area
  • Not willing to shave chest hair if needed to apply device
  • Patients on chronic ionotropic therapy
  • 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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Study Group

The study group will use the device one time daily (in the morning). The data will be reviewed and sent to the provider as detailed by the protocol.

sham comparator: Control Group

The control group will use the device one time daily (in the morning). The data will not be reviewed or acted upon.

Interventions

CPM Device + Monitoring

Daily device use \& data monitoring leading to symptomology assessment and notification to provider.

CPM Device

Daily device use

Primary outcome measure

  • Admission rate [ Time Frame: 7 months (during study) and 12 months prior to the study ]
  • Readmission rate [ Time Frame: 7 months (during study) and 12 months prior to the study ]
  • Healthcare Utilization [ Time Frame: 7 months (during study) and 12 months prior to the study ]
  • Cost of care [ Time Frame: 7 months (during study) and 12 months prior to the study ]
  • Quality of care [ Time Frame: 6 months ]
  • Patient satisfaction [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Emily Wycallis

9784351644emily.wycallis@analog.com

Locations

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Rebecca Rebain

864-455-7793Rebecca.Rebain@PrismaHealth.org

More Information

Sponsor

Analog Device, Inc.

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Analog Device, Inc. on 2024-02-23.