An interventional study of Perclose ProStyle™ Suture-Mediated Closure System and Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture) in Atrial Fibrillation, Atrial Septal Defect and Vascular Closure Device, sponsored by Ewha Womans University Mokdong Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Ewha Womans University Mokdong Hospital · Not applicable, Interventional, and Treatment
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ewha Womans University Mokdong Hospital is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing cardiologic procedures via femoral vein access who receive vascular closure using the Perclose ProStyle™ device
Device: Perclose ProStyle™ Suture-Mediated Closure System
Description: Patients undergoing cardiologic procedures via femoral vein access who receive conventional vascular closure (manual compression or figure-of-eight suture)
Other: Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
Vascular closure device applied to the femoral vein access site immediately following sheath removal.
Hemostasis achieved using standard manual compression or figure-of-eight suture technique at the femoral vein access site.
Time to Ambulation
Time elapsed from sheath removal until the patient achieves full ambulation
Time frame: Up to 24 hours post-procedure
Plan to share: No
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Ewha Womans University Mokdong Hospital