Status:
RECRUITING
Clinical Data Collection Study Using CPM System
Lead Sponsor:
Analog Device, Inc.
Collaborating Sponsors:
Columbia University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 bli...
Detailed Description
The current investigation is designed to be an observational study of the feasibility of using the CPM system. Its goal is to familiarize the study team with the CPM system, uncover potential challeng...
Eligibility Criteria
Inclusion
- 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)
- 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
- Under 18 years of age
- Patients with severe COPD (GOLD stage III or IV)
- Chronic Kidney Disease (eGFR \< 20)
- 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 inotropic 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)
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06007079
Start Date
December 6 2023
End Date
December 1 2025
Last Update
February 23 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032