NCT06199414

Vascular Closure With Novel External Compression Device: The LockeT Study

Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Kansas City Heart Rhythm Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 fellow's 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.

Conditions

• Atrial Fibrillation
• Hemostasis

Interventions

Type	Name	Description
DEVICE	Venous Closure	Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study