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.
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.
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
Parallel
Vascular closure with LockeT device
DeviceFor 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.
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.
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.
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.
Incidence of hematoma/ecchymosis
The incidence of hematoma/ecchymosis post-procedure will be assessed.
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,).
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