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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Vascular closure with LockeT device

For subjects that are assigned to the LockeT device arm, the healthcare professional will place the LockeT with suture above the wound to achieve compression instead of manually holding pressure on the sutures. After hemostasis is achieved and prior to ambulation the LockeT will be removed followed by suture removal.

Locations (6)

Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Centerpoint Medical Center Clinic
Independence, Missouri, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center Clinic
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States