Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT02159794
Status:
WITHDRAWN
Last Update Posted:
2015-03-26
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
Sponsor:
HLT Inc.
Organization:
Study Overview
Official Title:
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
HLT determined that design changes are necessary before reopening a study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HORIZON CANADA
Brief Summary:
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
Detailed Description:
Prospective, non-randomized, single arm, single-center first-in-man feasibility trial.
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?: