Tokyo, April 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061241) titled 'Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study' on April 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - atrial fibrillation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate and compare the efficacy of the VASCADE MVP venous vascular closure device (Haemonetics) versus the purse-string suture technique in achieving safe early ambulation following catheter ablation for atrial fibrillation. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Venous vascular closure device (VVCD) group: Hemostasis is performed using the VASCADE MVP system. Interventions/Control_2 - Control group: Hemostasis is performed using the purse-string suture technique.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients scheduled for catheter ablation therapy for atrial fibrillation. 2. Patients aged >= 18 and = 45) or low body weight (BMI < 20). 9. Patients meeting any of the following criteria: 10. History of allergy to bovine-derived products. 11. Presence of permanent hemostatic devices such as metal clips or permanent sutures. 12. Presence of severe complications (e.g., active infection, malignant tumor) that are considered to significantly affect the safety or efficacy evaluation of this study. 13. Patients who have an educational or employment hierarchical relationship with the investigator or co-investigators, which may compromise their voluntary participation in the study. 14. Other patients deemed inappropriate for the study by the investigator or co-investigators. Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 01 Month 05 Day Date of IRB - 2026 Year 03 Month 18 Day Anticipated trial start date - 2026 Year 04 Month 01 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=R000069377

Disclaimer: Curated by HT Syndication.