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

Last updated: October 25, 2024
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Cardiac Disease

Chest Pain

Treatment

Vascular closure with LockeT device

Clinical Study ID

NCT06078735
KCHRRF_LockeT II_0023
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be at least 18 years of age

  • Be able to provide consent

  • Presenting for planned procedures that require percutaneous venous punctures, suchas atrial fibrillation radiofrequency ablation, and where the physician utilizes aLockeT device or MC to close the wound.

Exclusion

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 plannedaccess 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 BetaHuman chorionic gonadotropin (HCG) will be checked in all females of thereproductive age group).

  • If the physician detects a formed hematoma prior to venous closure, that patientwill be excluded from the study.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Vascular closure with LockeT device
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Active - Recruiting

  • Centerpoint Medical Center

    Independence, Missouri 64057
    United States

    Active - Recruiting

  • Centerpoint Medical Center Clinic

    Independence, Missouri 64057
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

  • Research Medical Center Clinic

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

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