Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790344
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-03-04
Brief Title:
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientifics Investigational ICM System
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study LUX-Dx TRENDS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 objective of this study is to collect sensor data from insertable cardiac monitor systems
Detailed Description:
The primary objective of this study is to collect physiological measurement data and heart failure HF event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor ICM systems This study will not have pre-defined statistical endpoints To support the primary objective diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None