Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836311
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-04-13
Brief Title:
Single Perclose Escalation Technique for Vascular Closure in TAVR
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Single Perclose Escalation Technique for Vascular Closure in TAVR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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 examines in the safety and efficacy of using a single Perclose escalation technique SPET using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure with a 6F femoral sheath
Detailed Description:
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement TAVR The majority of experienced TAVR centers use two 6F Perclose ProGlide devices to close the primary vascular access site deployed prior to upsizing sheath size with closure completed at the end of the case the double preclose approach A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications complexity and cost but the safety of this is unknown This study examines in the safety and efficacy of using a single Perclose escalation technique SPET using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure with a 6F femoral sheath The use of Femoseal in mild bleedings and a second Perclose Proglide for moderate to severe bleedings Compare this SPET technique with double Preclose technique with two historical cohorts of patients One cohort of patients with SPET technique since started this technique and a second cohort with double perclose technique prior to starting SPET technique
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