Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-20
Brief Title:
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation PROSPERO-TAVI
Sponsor:
University of Catania
Organization:
University of Catania
Study Overview
Official Title:
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation The PROSPERO-TAVI Multi Center International Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
PROSPERO-TAVI
Brief Summary:
Transcatheter aortic valve implantation TAVI is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery Although historically excluded from the main randomized clinical trials patients with native bicuspid aortic valve BAV are commonly treated in daily TAVI practice Indeed several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve TAV patients Notably BAV is frequently associated with aortic dilatation 20 to 84 of BAV patients Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm 5 TAVI patients do not undergo treatment of the concomitant aortopathy but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment 67
The main aim of this ambispective multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography CTA assessment at follow-up
The main aim of this ambispective multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography CTA assessment at follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None