Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT02389894
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
Neuroprotection In Patients Undergoing Aortic Valve Replacement
Status:
COMPLETED
Status Verified Date:
2019-04
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:
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Detailed Description:
This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2U01HL088942-07 | NIH | None | https://reporter.nih.gov/quic… | View |