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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
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.
Yonsei University College of Medicine
Seoul, South Korea
Post-Procedural Patient Satisfaction Score
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.
Time frame: Periprocedural
Time to Hemostasis
Time required to achieve hemostasis after completion of the catheter ablation procedure will be compared between randomized groups.
Time frame: Periprocedural
Time to Ambulation
Time until the participant can stand and walk 6 meters without painful swelling requiring analgesia, superficial bleeding, or tissue bruising at the access site.
Time frame: Periprocedural
Time to Hospital Discharge
Time from the index procedure to hospital discharge will be compared between randomized groups.
Time frame: Periprocedural
Minor and Major Vascular Complications
Incidence of minor and major vascular access-site complications occurring within 30 days after the procedure.
Time frame: Within 30 days after the index procedure
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