Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT02073851
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Sponsor:
Keystone Heart
Organization:
Study Overview
Official Title:
A Prospective, Single Arm Feasibility Pilot Study to Evaluate the Safety and Performance of the TriGuard™HDH Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Status:
COMPLETED
Status Verified Date:
2015-08
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:
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
Detailed Description:
Prospective, single center, single arm pilot study enrolling up to 12 patients at a single investigational site in the netherlands. Patients meeting eligibility criteria for TAVR and none of the exclusion criteria will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
Study Oversight
Has Oversight DMC:
False
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?: