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Clinical Data Collection Study Using CPM System
Sponsor: Analog Device, Inc.
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 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.
Official title: Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2
Start Date
2023-12-06
Completion Date
2024-10-26
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
CPM Device
Wearable monitor
Locations (1)
Columbia University Medical Center
New York, New York, United States