Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03469570
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2018-03-12
Brief Title:
Assisted Fluid Management IDE Study
Sponsor:
Edwards Lifesciences
Organization:
Edwards Lifesciences
Study Overview
Official Title:
A Validation of the Assisted Fluid Management Feature
Status:
COMPLETED
Status Verified Date:
2019-05
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:
AFM
Brief Summary:
The primary objective of this study is to evaluate the performance of the Acumen Assisted Fluid Management AFM Feature in its ability to predict a subjects fluid responsiveness
Detailed Description:
The primary objective of this study is to evaluate the performance of the Acumen Assisted Fluid Management AFM Feature in its ability to predict a subjects fluid responsiveness
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature
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?:
None
Is an FDA AA801 Violation?:
None