Vascular Closure With Novel External Compression Device: The LockeT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.

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Detailed Description

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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

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Atrial Fibrillation Hemostasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects with Figure-of-eight (F-8) suture

This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure.

Venous Closure

Intervention Type DEVICE

Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Subjects with LockeT Device

This is the group of subjects for whom LockeT device is used for their venous closure.

Venous Closure

Intervention Type DEVICE

Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Interventions

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Venous Closure

Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No