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Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
Sponsor: Ewha Womans University Mokdong Hospital
Summary
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.
Official title: Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach ( Eight-CLOVER Trial)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-02-02
Completion Date
2028-12-31
Last Updated
2026-09-18
Healthy Volunteers
No
Interventions
Perclose ProStyle™ Suture-Mediated Closure System
Vascular closure device applied to the femoral vein access site immediately following sheath removal.
Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
Hemostasis achieved using standard manual compression or figure-of-eight suture technique at the femoral vein access site.
Locations (1)
Ewha Womans University Mokdong Hospital
Seoul, South Korea