Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-02-20 @ 12:55 PM
Study NCT ID:
NCT02697006
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Synchronized Cardiac Assist for Cardiogenic Shock
Sponsor:
Xenios AG
Organization:
Study Overview
Official Title:
Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
Status:
COMPLETED
Status Verified Date:
2020-09
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 purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: