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Tests a suture closure device for sealing the groin vein after heart procedures

Tests a suture closure device for sealing the vein after heart procedures.

Plain-language title generated from the registry record
Registry title: Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)

Key facts

Where
Seoul, South KoreaSee the site

Where in South Korea

  • Ewha Womans University Mokdong HospitalSeoul, South KoreaNo longer taking part

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Trial details

Who runs it
Ewha Womans University Mokdong Hospital
Trial code
NCT07827287
Record updated
18 September 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT07827287