Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199414
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-29
Brief Title:
Vascular Closure With Novel External Compression Device The LockeT Study
Sponsor:
Kansas City Heart Rhythm Research Foundation
Organization:
Kansas City Heart Rhythm Research Foundation
Study Overview
Official Title:
Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation The LockeT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
Single center retrospective review study comparing Figure of Eight suture to LockeT enrolling approximately 70 patients
Detailed Description:
The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge Manual compression MC the current standard of care requires bedrest often up to 8 hours This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters
Other methods of vascular closure include figure-of-eight F-8 a subcutaneous suture or Z-stitch or fellows stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma bleeding was also noted to be lower in F-8 group
In recent years invasive vascular closure devices have become popular However results continue to suggest that the risk versus benefit has not been definitively demonstrated LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside
Other methods of vascular closure include figure-of-eight F-8 a subcutaneous suture or Z-stitch or fellows stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma bleeding was also noted to be lower in F-8 group
In recent years invasive vascular closure devices have become popular However results continue to suggest that the risk versus benefit has not been definitively demonstrated LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside
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?:
False
Is an FDA AA801 Violation?:
None