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

RecruitingNAAges 18 Years - anyAllKansas City Heart Rhythm Research Foundation
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Vascular closure with LockeT device
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Where

6 sites
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, United States
Overland Park Regional Medical Center
Overland Park, United States
Centerpoint Medical Center Clinic
Independence, United States
Centerpoint Medical Center
Independence, United States
Research Medical Center Clinic
Kansas City, United States
Research Medical Center
Kansas City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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