Vascular Closure With Novel External Compression Device: The LockeT Study

Not yet recruiting

• Conditions: Hemostasis; Atrial Fibrillation
• Interventions: Device: Venous Closure

• Registration Number: NCT06199414
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

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 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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-29
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study Start: 2024-01
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

All participants must meet the following criteria to be included in this study.

• Subjects must be at least 18 years of age.
• Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
• Subjects must have undergone F-8 or LockeT for venous closure.

Exclusion Criteria

If a subject meet any of the following criteria will be excluded from study participation.

• Subjects under the age of 18.
• Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
• Subjects in which F-8 or a LockeT was not used.
• If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with LockeT Device	Venous Closure	This is the group of subjects for whom LockeT device is used for their venous closure.
Subjects with Figure-of-eight (F-8) suture	Venous Closure	This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure.

Primary Outcome Measures

Name	Time	Method
Effectiveness of LockeT device - Time to Ambulate	1 week	To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.; Time to no oozing/hemostasis (mins/hours)
Effectiveness of LockeT device - Time to no oozing/hemostasis	1 week	To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.; Time to no oozing/hemostasis (mins/hours)

Trial Locations

Locations (2)

Kansas City Heart Rhythm Institute - Roe Clinic; 🇺🇸 Overland Park, Kansas, United States

Overland Park Regional Medical Center; 🇺🇸 Overland Park, Kansas, United States