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

Launched by KANSAS CITY HEART RHYTHM RESEARCH FOUNDATION · Oct 3, 2023

Keywords

ClinConnect Summary

The LockeT II study is researching how well a device called the LockeT works compared to a method called Manual Compression for stopping bleeding after a specific heart procedure known as atrial fibrillation ablation. This study aims to help doctors learn which method is more effective at closing the small puncture made in the vein during the procedure. About 110 patients aged 18 and older who are scheduled for this procedure may be eligible to participate.

If you decide to join the study, you'll be randomly assigned to either the LockeT device group or the Manual Compression group. Before enrolling, you'll need to provide consent and meet certain criteria, like being able to follow the study's requirements and not being pregnant. It’s important to note that if the doctor finds any bleeding issues before the procedure, you won’t be able to take part. Throughout the study, you’ll receive care and follow-up to ensure your safety and health.

Gender

ALL

Eligibility criteria

• 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.