Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT05712161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
Sponsor:
Anteris Technologies Ltd.
Organization:
Study Overview
Official Title:
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DurAVR™ EFS
Brief Summary:
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Detailed Description:
The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions.
This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.
This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: