Comparing the LockeT External Compression Device and Manual Compression for Vascular Closure After Atrial Fibrillation Ablation

What this Trial Is About

This research aims to evaluate the effectiveness of the LockeT device for achieving hemostasis after venous procedures compared to the current standard method of Manual Compression MC. The study focuses on patients undergoing catheter ablation for atrial fibrillation and other arrhythmias, where vascular closure following large-bore sheath femoral access remains challenging. The trial is prospective, randomized, and conducted at a single center, enrolling around 110 patients. Participants are randomly assigned to one of two groups the LockeT device group or the Manual Compression group. In the LockeT group, a healthcare professional places the LockeT device with suture above the wound to apply compression, aiming to mimic manual pressure but without continuous bedside presence. After hemostasis is achieved and before walking, the device and sutures are removed. The Manual Compression group receives the standard care of manual pressure to close the access site wound. During the study, researchers will assess the effectiveness of the LockeT device within 2 days following the procedure. They will also evaluate benefits to patients, physicians, and nursing staff, measure patient discomfort, track hematoma or bruising incidence, monitor safety, and compare labor and device costs. Participants will be closely monitored during this short follow-up period to understand outcomes related to vascular closure methods.

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