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ENROLLING BY INVITATION
NCT07827287
NA

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

View on ClinicalTrials.gov

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

DEVICE

Perclose ProStyle™ Suture-Mediated Closure System

Vascular closure device applied to the femoral vein access site immediately following sheath removal.

OTHER

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