Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-01-13
Brief Title:
Use of DurAVR THV System in Subjects With Severe Aortic Stenosis Early Feasibility Study
Sponsor:
Anteris Technologies Ltd
Organization:
Anteris Technologies Ltd
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:
None
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?:
None