Venous Closure System After AF Ablation

VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial

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.

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.