Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06078267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure (Beta Study)
Sponsor:
Analog Device, Inc.
Organization:
Study Overview
Official Title:
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose for this study is to support the hypothesis (pilot data) that the use of the CardioPumonary Management (CPM) system reduces the rate of heart failure (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.
Detailed Description:
This study is meant primarily to determine the clinical and financial efficacy of the CardioPulmonary Management (CPM) system in reducing heart failure (HF) events and their associated cost. Although patients will use an investigational device as part of this pilot, the device is passive and of minimal risk to the patient. No treatment changes will be decided on the CPM data solely. All CPM data will be confirmed with a symptomology assessment and the patient's care provider will make the final determination whether a change of treatment is appropriate or not.
There will be two groups, the study cohort and the control cohort. After informed consent is obtained, the patient will be randomized. The randomization will occur in the Electronic Data Capture system (EDC) and will be 2:1.
The study group will receive all aspects of the CPM monitoring system as a supplement to their normal care routine. They will have one visit at the beginning of the study and one visit 6 months later. Patients in the study group will receive the CPM device at visit 1 and use the CPM device once a day during the monitoring period of the study (6 months) and the data will be monitored by the ADI (Analog Devices, Inc.) Care Team. During this period, the research team will monitor the patient's chart, recommended once every 2 weeks, looking for Chronic Heart Failure (CHF) outcomes (i.e. medicine changes, hospitalizations, Emergency Room visits, clinic visits). After the 6- month monitoring period, visit 2 will occur. The site research team will continue to monitor the patient's chart for an additional 4 weeks after visit 2 to capture clinical outcomes. Patients using the device will also have the phone number for ADI Tech Support. Patients will be instructed to call this number if they believe their device is malfunctioning or if they have questions on how to use it. Device malfunctions that can be fixed remotely are not classified as adverse events (unless they result in harm). Device malfunctions that require subject to return for an office visit are considered adverse events.
The control group will not receive the CPM monitoring system and will not participates in the visit activities. They will sign the consent form and go through the screening process as usual. Their chart will be monitored for 7 months, recommended once every 2 weeks, to have their outcomes captured. At the beginning of the study, they will receive a phone call to confirm their medications and past medical history (as detailed in the medical history section below). They will receive a call after 6 months to terminate the study, followed by an additional one month of monitoring.
There will be two groups, the study cohort and the control cohort. After informed consent is obtained, the patient will be randomized. The randomization will occur in the Electronic Data Capture system (EDC) and will be 2:1.
The study group will receive all aspects of the CPM monitoring system as a supplement to their normal care routine. They will have one visit at the beginning of the study and one visit 6 months later. Patients in the study group will receive the CPM device at visit 1 and use the CPM device once a day during the monitoring period of the study (6 months) and the data will be monitored by the ADI (Analog Devices, Inc.) Care Team. During this period, the research team will monitor the patient's chart, recommended once every 2 weeks, looking for Chronic Heart Failure (CHF) outcomes (i.e. medicine changes, hospitalizations, Emergency Room visits, clinic visits). After the 6- month monitoring period, visit 2 will occur. The site research team will continue to monitor the patient's chart for an additional 4 weeks after visit 2 to capture clinical outcomes. Patients using the device will also have the phone number for ADI Tech Support. Patients will be instructed to call this number if they believe their device is malfunctioning or if they have questions on how to use it. Device malfunctions that can be fixed remotely are not classified as adverse events (unless they result in harm). Device malfunctions that require subject to return for an office visit are considered adverse events.
The control group will not receive the CPM monitoring system and will not participates in the visit activities. They will sign the consent form and go through the screening process as usual. Their chart will be monitored for 7 months, recommended once every 2 weeks, to have their outcomes captured. At the beginning of the study, they will receive a phone call to confirm their medications and past medical history (as detailed in the medical history section below). They will receive a call after 6 months to terminate the study, followed by an additional one month of monitoring.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: