Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009588
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-08-12
Brief Title:
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement The AAD-CHOICE
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement The AAD-CHOICE
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement
Detailed Description:
Ascending aortic AA dilation is a common feature in patients with aortic stenosis AS especially in those with bicuspid aortic valve BAV For patients undergoing surgical aortic valve replacement SAVR current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture
Transcatheter aortic valve replacement TAVR has profoundly changed the clinical management of AS patients who cannot tolerate SAVR For patients who are candidates for TAVR simultaneous repair of a dilated AA can be technically difficult The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear Moreover there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA 45mm undergoing TAVR
Transcatheter aortic valve replacement TAVR has profoundly changed the clinical management of AS patients who cannot tolerate SAVR For patients who are candidates for TAVR simultaneous repair of a dilated AA can be technically difficult The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear Moreover there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA 45mm undergoing TAVR
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