LockeT II Study for Vascular Closure After Atrial Fibrillation Ablation

This study, called LockeT II, is looking at a new way to close wounds after procedures like atrial fibrillation ablation (a treatment for an irregular heartbeat). Currently, doctors often use manual compression (holding pressure on the wound) which can mean long bed rest. This study compares manual compression to a device called LockeT. The LockeT device uses a suture (stitch) to apply pressure, aiming to achieve the same benefits as manual compression without needing a healthcare professional to hold pressure. The study wants to see how effective the LockeT device is at closing the wound within two days. You might be able to join if you are at least 18 years old and are having a procedure that requires a venous puncture, like atrial fibrillation ablation. The study is currently unclear on its recruitment status.

Study design
This is a single-center, randomized study, meaning participants are randomly assigned to either receive the LockeT device or manual compression. Approximately 110 patients will be enrolled.
What's involved
For participants assigned to the LockeT device, a healthcare professional will place the device with a suture above the wound for compression. The LockeT will be removed before you can walk around.
Compensation
Not stated in the trial record.
Follow-up
The effectiveness of the LockeT device will be measured at 2 days after the procedure.

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NCT06078735

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

Recruiting
NAAges 18+InterventionalSupportive care
Kansas City Heart Rhythm Research Foundation
~110 participants
Updated 2024-10-29 on ClinicalTrials.gov
What's tested:Vascular closure with LockeT device

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness of using the LockeT suture retention device
Measured over 2 Days
Atrial Fibrillation
Hemostasis
6 sites across 2 states
Missouri4
Kansas2
  • Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

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Eligibility criteria

Inclusion

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

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.
  • Effectiveness of using the LockeT suture retention device2 Days

    Effectiveness of using the LockeT suture retention device to gain hemostasis after venous procedures as compared to standard Manual Compression (MC) will be assessed.