Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691245
Status:
UNKNOWN
Last Update Posted:
2020-12-31
First Post:
2020-12-20
Brief Title:
3D US Guided Femoral Artery Access for TAVI
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
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:
3D-US-TAVI
Brief Summary:
Rationale Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures Although steadily declining over the past years through smaller diameter devices and use of ultrasound major complications still occur in 3-4 of patients Femoral access is often obtained using 2D US guidance already New 3D US probes can aid in increasing anatomical awareness This can improve first pass success during procedures Furthermore for new closure devices entering the artery at a straight angle at precisely 12 oclock probably reduces complications Therefore the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None