Venous Closure System After AF Ablation

NCT07814144 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Phase 4

Started

2026-01-06

Last updated

2026-09-10

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Perclose ProGlide™Figure-of-8 suture

Perclose ProGlide™: At the end of the procedure, Perclose ProGlide™ will be applied to femoral venous access sites using sheaths ≥8 Fr. Additional manual compression may be performed at the operator's discretion. A vertical mattress skin suture may be placed and removed the following day.

Figure-of-8 suture: At the end of the procedure, a figure-of-8 suture will be applied to the femoral venous access site, followed by manual compression as needed. The suture will be removed the following day.

Study summary

This prospective, randomized, participant-blinded study will compare a suture-based venous closure system (Perclose ProGlide™) with a conventional figure-of-8 suture for femoral venous access-site closure in patients undergoing catheter ablation for atrial fibrillation. A total of 90 participants will be randomized in a 1:1 ratio to the venous closure system group or the figure-of-8 suture group. The primary objective is to evaluate patient satisfaction with the post-procedural vascular closure strategy. Secondary outcomes include time to hemostasis, time to ambulation, time to discharge, and the incidence of minor and major vascular complications within 30 days. Participants will complete a post-procedural satisfaction questionnaire after suture removal, and vascular access-site complications will be assessed during hospitalization and follow-up through 30 days.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: 1. Age ≥19 years or legal age to provide informed consent under Korean law. 2. Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr. 3. Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device. 4. Written informed consent and agreement to post-procedural follow-up and outpatient visits. 5. Considered able to complete follow-up during the study period. Exclusion Criteria: 1. History of prolonged hospitalization due to vascular access-related complications. 2. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy. 1\. History of prolonged hospitalization due to vascular access-related complications. 2\. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3\. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4\. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.

Primary outcome measure(s)

Post-Procedural Patient Satisfaction Score — Periprocedural
Patient satisfaction with the vascular closure method will be assessed using the protocol-specified Post-Procedural Patient Satisfaction Questionnaire. The total score ranges from 0 to 60 points and will be compared between randomized groups.

Trial sites (1)

Facility	City	Region	Status
Yonsei University College of Medicine	Seoul	South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07814144 on ClinicalTrials.gov ↗ ← All trials in South Korea