Recruiting

CPM

Sponsor:

Analog Device, Inc.

Code:

NCT06007131

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioPumlonary Management System

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 against those who are not. This can either be done using institutions averages, if available, or through a control group.

Conditions

Heart Failure

Study ID

NCT06007131

Start date

Dec 15, 2023

Status verified date

Feb, 2024

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Dec 1, 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

75 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 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.

no intervention: Control Group

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

Interventions

CardioPumlonary Management System

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.

Primary outcome measure

  • Admission Rate [ Time Frame: 7 months ]
  • Readmission Rate [ Time Frame: 7 months ]
  • Healthcare utilization [ Time Frame: 7 months ]
  • Patient Satisfaction [ Time Frame: 7 months ]
  • Cost of Care [ Time Frame: 7 months (during study) and 12 months prior to the study ]
  • Quality of Care [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Emily Wycallis

9784351644emily.wycallis@analog.com

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

(321) 843-9657George.Ngo@orlandohealth.com

Principal Investigator:

Shahid Qamar, MD

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.