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

NCT07827287 | Enrolling By Invitation

• 1 other identifier: CLOVER
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Septal Defect; Atrial Fibrillation; Vascular Closure Device

Keywords

Perclose ProStyle; Femoral Vein Access; Catheter Ablation; Left Atrial Appendage Occlusion; Leadless Pacemaker

Outcome Measures

Primary Outcomes (1)

• Time to Ambulation

  Time elapsed from sheath removal until the patient achieves full ambulation

  Up to 24 hours post-procedure

Study Arms (2)

experimental Group (Perclose ProStyle)

EXPERIMENTAL

Patients undergoing cardiologic procedures via femoral vein access who receive vascular closure using the Perclose ProStyle™ device

Device: Perclose ProStyle™ Suture-Mediated Closure System

Control Group (Conventional Closure)

ACTIVE COMPARATOR

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)

Interventions

Perclose ProStyle™ Suture-Mediated Closure System DEVICE

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

experimental Group (Perclose ProStyle)

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.

Control Group (Conventional Closure)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead
• Ewha Womans University Seoul Hospital: collaborator

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)