Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Kansas City Heart Rhythm Research Foundation

Status

Enrolling

Conditions

Hemostasis

Atrial Fibrillation

Treatments

Device: Vascular closure with LockeT device

Study type

Interventional

Funder types

Other

Identifiers

NCT06078735

KCHRRF_LockeT II_0023

Details and patient eligibility

About

The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.

Full 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 decrease in complication rates due to refinement in ablation tools and techniques, achieving vascular hemostasis following large-bore sheath femoral access remains a challenge. Thus, MC remains the current standard of care. However, MC requires up to 8 hours of prolonged bedrest, which is associated with longer length of stay and complications from indwelling catheters.

Another method of vascular closure is the figure-of-eight (FoE) stitch - a subcutaneous suture that has been evaluated to achieve homeostasis following major cardiovascular procedures.

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. Instead, the LockeT is a new suture retention device designed to closely mimic manual compression by distributing the tension of a FoE stitch over a larger surface area. In such a way, patients can have the benefits of MC without a healthcare professional to stand bedside.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be at least 18 years of age
Be able to provide consent
Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.

Exclusion criteria

Under the age of 18
Unable to or unwilling to provide consent
Cannot comply with study requirements
Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
Subjects whose physician does not use LockeT or MC to close the venous puncture.
Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.