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Enrolling by invitation

NCT Number: NCT07827287

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Closure Device

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 19 years or older undergoing cardiologic procedures via femoral vein access
  • Patients who provide written informed consent to participate in the study

Exclusion criteria

  • Patients with active systemic infection or local infection at the vascular access site
  • Patients with known severe allergy to contrast media or device components
  • Patients unable to provide informed consent

Treatment and study plan

Perclose ProStyle™ Suture-Mediated Closure System

Device

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

Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)

Other

Hemostasis achieved using standard manual compression or figure-of-eight suture technique at the femoral vein access site.

Primary outcomes

  1. Time to Ambulation

    Time frame: Up to 24 hours post-procedure

    Time elapsed from sheath removal until the patient achieves full ambulation

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Collaborators

  • Ewha Womans University Seoul Hospital

Registry information

Official study title

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

Acronym: Eight-CLOVER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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