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Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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.
What is being tested
- Vascular closure with LockeT device (device)
Sponsor: Kansas City Heart Rhythm Research Foundation · Participants: 110 · Started: Oct 2, 2023
Contact the study team
- Donita Atkins · Phone: 816-651-1969
Official record on ClinicalTrials.gov — NCT06078735
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.