Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)

Overview

The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8 French or larger.Patients receiving cardiac interventions-such as atrial fibrillation catheter ablation, leadless pacemaker insertion, atrial septal defect (ASD) patch closure, or left atrial appendage occlusion (LAAO)-will be randomly assigned in a 1:1 ratio to either the intervention group (using the Perclose ProStyle™ device for vascular closure) or the control group (using conventional manual compression or figure-of-eight suture).The primary outcome of the study is the time to ambulation after the procedure. Secondary outcomes include time to hemostasis, time to discharge eligibility, patient satisfaction scores, and the incidence of vascular complications within 30 days post-procedure.

Cardiac interventional procedures using large-bore sheaths (\>= 8 French) via femoral vein access are associated with an increased risk of vascular access-related complications, prolonged bed rest, and delayed ambulation. While suture-mediated vascular closure devices like Perclose ProStyle™ have shown benefits in reducing hemostasis and recovery times in Western populations, prospective multi-center data in Korean patients remain limited.This prospective, randomized, open-label, parallel-group multi-center study aims to enroll a total of 200 patients across Ewha Womans University Mokdong Hospital and Seoul Hospital. Patients will be evaluated at baseline, on the day of the procedure, prior to discharge, and via a 30-day follow-up visit or phone call to assess safety and efficacy endpoints.