Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Kansas City Heart Rhythm Research Foundation
Summary
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.
Description
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 (F…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceVascular 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 ClinicOverland Park, Kansas
- Overland Park Regional Medical CenterOverland Park, Kansas
- Centerpoint Medical Center ClinicIndependence, Missouri
- Centerpoint Medical CenterIndependence, Missouri
- Research Medical Center ClinicKansas City, Missouri
- Research Medical CenterKansas City, Missouri