Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024369
Status:
WITHDRAWN
Last Update Posted:
2024-05-16
First Post:
2023-08-28
Brief Title:
Study of ADI CardioPulmonary Management CPM System
Sponsor:
Analog Device Inc
Organization:
Analog Device Inc
Study Overview
Official Title:
Study of ADI CardioPulmonary Management CPM System
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in staff resources sponsor decided not to pursue study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is meant primarily collect CardioPulmonary Management CPM data from daily usage and compare it to the clinical course of a patient For this study the only aspect of the CPM solution that will be used will be the device itself and the mobile application to assign devices to patients The patients will be assigned a device at visit one and take the device home They will use the device once daily when they first wake up for 6 months The patient will come in for visit 2 to return the device
Detailed Description:
Patients that participate in this study will be using a wearable device for 6 months At their initial visit visit 1 patients will undergo a brief physical exam have their medical history and medications recorded and be fit to a device With their clinical or clinician delegate the patient will have their baseline reading with the device The patient will then be taught how to use the device at home and go through 2 practice patient-initiated measurements The patient will also complete two surveys as a part of visit 1 These surveys can be done at the visit or at home within 7 days of the visit
Details of all available history of Chronic Heart Failure CHF disease including surgical interventions related to CHF CHF risk factors or CHF comorbidities will be recorded via a chart pull after the visit The number of previous CHF-related hospitalizations the patients latest CHF diagnosis classification and date of last hospitalization number of days since will be specifically noted This includes notes about the current condition of the patient and their congestion and fluid status Current New York Heart Association NYHA classification will be pulled as well or assigned during the physical exam portion Recent BNP brain natriuretic peptide creatinine Left Ventricular Ejection Fraction LVEF chest Xray and other relevant labs will also be pulled from the chart and with vaccination status and dates for the following vaccines COVID 19 flu and pneumonia This is the first chart review of two that is required for the study
After visit 1 the patient will use the device once daily for 6 months After 6 months the patient will return for visit 2 At visit two the patient will have a brief physical exam and return the device The patient will complete the same two surveys and an additional survey about their perception of the device
30 days after visit 2 a second targeted chart review will occur Details of the patients clinical course while they were using the device and for an additional 30 days after will be recorded While the chart review will be targeted to the CHF clinical course such as Emergency room visits hospitalizations skilled nursing facility visits outpatient checkups and other CHF related notes other relevant information will be collected as well The most recent NYHA classification will be pulled or assigned at visit 2 The most recent BNP creatinine LVEF chest Xray and other relevant labs will be pulled
Details of all available history of Chronic Heart Failure CHF disease including surgical interventions related to CHF CHF risk factors or CHF comorbidities will be recorded via a chart pull after the visit The number of previous CHF-related hospitalizations the patients latest CHF diagnosis classification and date of last hospitalization number of days since will be specifically noted This includes notes about the current condition of the patient and their congestion and fluid status Current New York Heart Association NYHA classification will be pulled as well or assigned during the physical exam portion Recent BNP brain natriuretic peptide creatinine Left Ventricular Ejection Fraction LVEF chest Xray and other relevant labs will also be pulled from the chart and with vaccination status and dates for the following vaccines COVID 19 flu and pneumonia This is the first chart review of two that is required for the study
After visit 1 the patient will use the device once daily for 6 months After 6 months the patient will return for visit 2 At visit two the patient will have a brief physical exam and return the device The patient will complete the same two surveys and an additional survey about their perception of the device
30 days after visit 2 a second targeted chart review will occur Details of the patients clinical course while they were using the device and for an additional 30 days after will be recorded While the chart review will be targeted to the CHF clinical course such as Emergency room visits hospitalizations skilled nursing facility visits outpatient checkups and other CHF related notes other relevant information will be collected as well The most recent NYHA classification will be pulled or assigned at visit 2 The most recent BNP creatinine LVEF chest Xray and other relevant labs will be pulled
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?:
True
Is an FDA AA801 Violation?:
None