Clinical Data Collection Study Using CPM System
Key facts
- Who runs it
- Analog Device, Inc.
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 2 people enrolled
- Started
- 6 Dec 2023
- Ended
- 26 Oct 2024
- Type of study
- Interventional
- Treatments tested
- CPM Device
- Record updated
- 19 August 2026
- Why it stopped
- Terminated due to operational considerations
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- NYHA Class III-IV
- NYHA Class II HF with one or more of the following:; Chronic Kidney Disease (eGFR<60); 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)
Who cannot take part
- Patients on chronic inotropic therapy
- Skin allergies or skin sensitivities to silicone-based adhesives
- Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
- Chronic Kidney Disease (eGFR < 20)
- 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
- Pregnancy
- Skin breakdown on the left chest or breast area
- Not willing to shave chest hair if needed to apply device
- No cellular coverage (Patient's Home)
Where in United States
- Columbia University Medical CenterNew York, United States
About the trial
What the trial wants to find out
This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.
The group in the trial
- Device UseTreatment being tested
Patients will be given the CPM device to take home and use once daily
Treatment: CPM Device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
- Record updated
- 19 August 2026