Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362668
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-02-21
Brief Title:
EU Sites Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System FASTR-EU
Sponsor:
Reprieve Cardiovascular Inc
Organization:
Reprieve Cardiovascular Inc
Study Overview
Official Title:
EU Sites Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System DMS FASTR-EU
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FASTR-EU
Brief Summary:
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy ODT in the treatment of patients diagnosed with acute decompensated heart failure ADHF The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None