Clinical Trial: A multicenter prospective study of the efficacy of figure-of-eight and modified figure-of-eight sutures for femoral venous hemostasis after catheter ablation (Japan)

Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062628) titled 'A study comparing two figure-of-eight suture techniques for femoral venous hemostasis after atrial fibrillation ablation' on Aug. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kumamoto Rosai Hospital

Condition: Condition - Symptomatic paroxysmal or persistent atrial fibrillation scheduled for pulmonary vein isolation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare conventional figure-of-eight suturing (FoE) with modified figure-of-eight suturing (mFoE) for femoral venous hemostasis after atrial fibrillation catheter ablation. The primary outcome is the non-inferiority of time to hemostasis (TTH; the time from sheath removal to confirmed hemostasis). As a secondary outcome, a safety-prioritized hierarchical composite comprising (1) serious vascular access-site complications, (2) bleeding complications requiring additional manual compression, (3) access-site hematoma, and (4) TTH will be evaluated descriptively using the win ratio; no confirmatory superiority or non-inferiority claim will be made for this composite. Individual component results will also be reported as supportive analyses. Participants will be allocated 1:1 by alternation according to the order of participant registration (quasi-randomization). Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Conventional figure-of-eight suture (FoE) group: after completion of ablation, a conventional FoE suture is placed once, with the needle passed perpendicular to the femoral venous sheath. Time to hemostasis is measured after sheath removal. Bed rest is discontinued after 4 hours once hemostasis is confirmed. The access site is followed through hospital discharge, including ultrasonographic assessment on the day after the procedure. Interventions/Control_2 - Modified figure-of-eight suture (mFoE) group: after completion of ablation, an mFoE suture is placed once. The needle is passed parallel to the femoral venous sheath to avoid sheath contact and captures only subcutaneous tissue. Subsequent measurement of time to hemostasis, 4-hour bed rest, follow-up through hospital discharge, and next-day ultrasonographic assessment are identical to those in the FoE group.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Age 20 years or older; (2) symptomatic paroxysmal or persistent atrial fibrillation; (3) scheduled to undergo atrial fibrillation catheter ablation including pulmonary vein isolation; and (4) provision of written informed consent. Key exclusion criteria - Patients who do not provide written informed consent to participate in the study. Target Size - 400

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2023 Year 01 Month 07 Day Date of IRB - 2023 Year 02 Month 03 Day Anticipated trial start date - 2023 Year 02 Month 07 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071689

Disclaimer: Curated by HT Syndication.