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Enrolling By Invitation
NCT07827287
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
Conditions: Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Ewha Womans University Mokdong Hospital
Location: Ewha Womans University Mokdong Hospital Seoul
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07827287). StuddyBuddy aggregates publicly available trial information.