Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007079
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-08-18
Brief Title:
Clinical Data Collection Study Using CPM System
Sponsor:
Analog Device Inc
Organization:
Analog Device Inc
Study Overview
Official Title:
Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
Status:
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:
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
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 challenges in its deployment assess its predictive ability and ultimately define clinical protocols to react to CPM generated information The next phase of investigation will be a pilot study of the efficacy of using the CPM system to prevent heart failure hospitalizations
The patient will use the CPM device once daily during the first 5 months of the study Patient records will be retrospectively reviewed over those 5 months plus an additional 30 days following the final CPM measurement to assess for any CHF-related events
BaselineInitial Visit Visit 1
At this visit the start of the study the information described in the Baseline Assessments section will be collected The study will be re-described to the participant The study team will then set up the device for the individual patient by making adjustments as needed to address patient specific anatomy ensuring that the sensors are all contacting the appropriate chest areas and confirming the measurements on the CPM Web application The patient will be shown how to apply and replace the adhesive on the device how to position the device how to take a measurement with the device and how to store the device on the Base Station The trained provider will then register the baseline reading for the CPM device using the CPM Mobile App Informational material about using the device refreshing adhesives and interpreting device LEDs and chimes will be provided to each patient Each patient will be reminded to take a measurement with their CPM at the same time each day preferably when they first wake up and instructed to follow the medical regimen prescribed by their physician
Between Visits
Between visits caregivers will not have any access to the data being collected on the CPM System They should perform their usual standard of care on these patients Participants will receive one call from the study team after 1 week of monitoring to check in about the progress of the study ie if protocols are being followed correctly if the CPM device is working properly and if adherence is satisfactory If the participant is found to have problems with the device a follow up at week 2 can be scheduled The check-in conversation topics should focus on any ease of use issues and address any technical barriers impacting compliance
Follow-up Visit Visit 2
On this visit which will take place at the end of the 5 months the study team will make arrangements for the patient to return to the office for a check-up and return the device the same tests as described in the physical examination section Patients will also be asked about their perception on ease of use impact on day to day activities and overall satisfaction with the CPM system Thirty days following the last measurement the study team will review the patients records for all HF related events and treatment changes Study protocol will also include a phone call to the patient to inquire if they had any heart failure events during this time
Post-Monitoring Data review
After the completion of the monitoring the study team will analyze the de-identified data from the CPM system and correlate it with clinical events obtained from patients and their medical records Threshold events flagged in the CPM data will then be compared to clinical data to determine the CPMs performance characteristics sensitivity specificity PPV NPV and AUC ROC and median prediction time for HF events
The patient will use the CPM device once daily during the first 5 months of the study Patient records will be retrospectively reviewed over those 5 months plus an additional 30 days following the final CPM measurement to assess for any CHF-related events
BaselineInitial Visit Visit 1
At this visit the start of the study the information described in the Baseline Assessments section will be collected The study will be re-described to the participant The study team will then set up the device for the individual patient by making adjustments as needed to address patient specific anatomy ensuring that the sensors are all contacting the appropriate chest areas and confirming the measurements on the CPM Web application The patient will be shown how to apply and replace the adhesive on the device how to position the device how to take a measurement with the device and how to store the device on the Base Station The trained provider will then register the baseline reading for the CPM device using the CPM Mobile App Informational material about using the device refreshing adhesives and interpreting device LEDs and chimes will be provided to each patient Each patient will be reminded to take a measurement with their CPM at the same time each day preferably when they first wake up and instructed to follow the medical regimen prescribed by their physician
Between Visits
Between visits caregivers will not have any access to the data being collected on the CPM System They should perform their usual standard of care on these patients Participants will receive one call from the study team after 1 week of monitoring to check in about the progress of the study ie if protocols are being followed correctly if the CPM device is working properly and if adherence is satisfactory If the participant is found to have problems with the device a follow up at week 2 can be scheduled The check-in conversation topics should focus on any ease of use issues and address any technical barriers impacting compliance
Follow-up Visit Visit 2
On this visit which will take place at the end of the 5 months the study team will make arrangements for the patient to return to the office for a check-up and return the device the same tests as described in the physical examination section Patients will also be asked about their perception on ease of use impact on day to day activities and overall satisfaction with the CPM system Thirty days following the last measurement the study team will review the patients records for all HF related events and treatment changes Study protocol will also include a phone call to the patient to inquire if they had any heart failure events during this time
Post-Monitoring Data review
After the completion of the monitoring the study team will analyze the de-identified data from the CPM system and correlate it with clinical events obtained from patients and their medical records Threshold events flagged in the CPM data will then be compared to clinical data to determine the CPMs performance characteristics sensitivity specificity PPV NPV and AUC ROC and median prediction time for HF events
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None