Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510855
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
DurAVR THV EU-EFS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DurAVR THV System European Early Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
A prospective non-randomized single-arm multi-center study designed to evaluate the safety and feasibility of DurAVR THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves
Detailed Description:
The DurAVR THV System is a novel balloon-expandable single-piece transcatheter aortic valve
The study will enroll up to 40 subjects with severe symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR THV prosthesis
Subjects will be consented for follow-up to 5 years
The study will enroll up to 40 subjects with severe symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR THV prosthesis
Subjects will be consented for follow-up to 5 years
Study Oversight
Has Oversight DMC:
None
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?:
None