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

Study Overview
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Brief Summary
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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.

Detailed Description
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The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite decrease in complication rates due to refinement in ablation tools and techniques, achieving vascular hemostasis following large-bore sheath femoral access remains a challenge. Thus, MC remains the current standard of care. However, MC requires up to 8 hours of prolonged bedrest, which is associated with longer length of stay and complications from indwelling catheters. Another method of vascular closure is the figure-of-eight (FoE) stitch - a subcutaneous suture that has been evaluated to achieve homeostasis following major cardiovascular procedures. In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. Instead, the LockeT is a new suture retention device designed to closely mimic manual compression by distributing the tension of a FoE stitch over a larger surface area. In such a way, patients can have the benefits of MC without a healthcare professional to stand bedside.

Official Title
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Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Conditions
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Atrial Fibrillation, Hemostasis

Intervention / Treatment
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* Device: Vascular closure with LockeT device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1 to LockeT device or Manual Compression.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LockeT<br>These are the patients assigned for LockeT device arm to close the access site wound. | Device: Vascular closure with LockeT device<br>* 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.<br>|
| No Intervention: Manual compression<br>These are the patients assigned for Manual Compression arm to close the access site wound. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of using the LockeT suture retention device | Effectiveness of using the LockeT suture retention device to gain hemostasis after venous procedures as compared to standard Manual Compression (MC) will be assessed. | 2 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient, physician, and nursing staff benefits | Patient, physician, and nursing staff benefits of the LockeT device will be assessed via LockeT device questionnaire with a scale of 1 to 5, 1 strongly disagree and 5 strongly agree. | 2 Days | 
| Patient discomfort with Locket device | Pain discomfort will be assessed via Locket device questionnaire with a scale of 1 to 5, 1 strongly disagree and 5 strongly agree. | 2 Days | 
| Incidence of hematoma/ecchymosis | The incidence of hematoma/ecchymosis post-procedure will be assessed. | 2 Days | 
| Safety of LockeT device | Safety of LockeT device will be assessed by the incidence of adverse events, including but not limited to: vascular complications, like atrioventricular (AV) fistula, retroperitoneal bleed, surgical exploration of the groin (thrombin injection, open surgery or ligation); need for blood transfusion, defined as a 2 gm post-procedure drop in hemoglobin, or symptoms of anemia,). | 2 Days | 
| Comparison of Manual Compression labor cost and Locket device cost | Manual Compression labor cost and Locket device cost will be compared | 2 Days |