Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06078280 |
| Other study ID # |
BETA-DESERTOASIS |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2023 |
| Est. completion date |
November 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Analog Device, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
