Clinical Trial: Thoracoscopic LAAO After AF Ablation Trial (Japan)

Tokyo, Sept. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063004) titled 'A Study of Thoracoscopic Left Atrial Appendage Occlusion to Discontinue Oral Anticoagulation After Atrial Fibrillation Ablation' on Sept. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Medical Corporation Tokushukai Chibanishi General Hospital

Condition: Condition - Nonvalvular atrial fibrillation with maintenance of sinus rhythm after catheter ablation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To exploratorily evaluate the efficacy, safety, and feasibility of a strategy of thoracoscopic left atrial appendage occlusion followed by oral anticoagulation discontinuation compared with continued oral anticoagulation in high-risk patients with no clinically documented recurrence of AF, AFL, or AT for at least 12 months after catheter ablation. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Oral anticoagulation (OAC) continuation group. OAC with a direct oral anticoagulant (DOAC) or warfarin is continued according to current guidelines and standard clinical practice. The choice and dose of OAC and any dose adjustments are determined by the treating physician based on renal function, age, body weight, concomitant medications, bleeding risk, and other clinical factors. The primary assessment period is 12 months after randomization, and all participants are followed for 24 months. After completion of the 12-month primary assessment, crossover to thoracoscopic left atrial appendage occlusion is permitted for patients who request it after reassessment of eligibility. Interventions/Control_2 - OAC discontinuation strategy using thoracoscopic left atrial appendage occlusion. In principle, isolated thoracoscopic left atrial appendage occlusion using AtriClip is performed within 30 days after randomization under general anesthesia with single-lung ventilation. Concomitant surgical ablation, including Maze procedures or pulmonary vein isolation, is not permitted. After surgery, OAC is resumed after adequate hemostasis and continued for at least 45 days and until assessment for OAC discontinuation has been completed by imaging performed 45-90 days after surgery. Complete LAA closure is assessed by ECG-gated contrast-enhanced cardiac CT, or by transesophageal echocardiography when CT is not feasible. OAC may be discontinued at the treating physician's discretion when complete closure is confirmed and there is no left atrial or residual LAA thrombus, recurrence of AF/AFL/AT, or other indication for continued OAC. OAC is continued if incomplete closure, thrombus, atrial arrhythmia recurrence, or another indication for anticoagulation is present. All participants are followed for 24 months after randomization.

Eligibility: Age-lower limit - 18 years-old =18 years at the time of informed consent. 2.History of catheter ablation for nonvalvular atrial fibrillation. 3.At least 12 months have elapsed since the last catheter ablation. 4.No AF, AFL, or AT lasting >=30 seconds has been documented during the 12 months before enrollment by available 12-lead ECG, portable ECG, Holter monitoring, implanted cardiac devices, or other rhythm recordings, and sinus rhythm has been confirmed on at least two occasions, including at least one assessment within 30 days before enrollment. 5.CHADS2 score >=2 at enrollment. 6.HAS-BLED score >=2 at enrollment. 7.An indication for continued OAC according to current clinical guidelines and the treating cardiologist, with OAC being taken at enrollment. 8.Considered by both a cardiologist and cardiovascular surgeon to be medically eligible for either continued OAC or an OAC discontinuation strategy using thoracoscopic LAAO. 9.Able to provide written informed consent voluntarily. Key exclusion criteria - Patients will be excluded if any of the following apply:

1.Mechanical prosthetic valve or moderate/severe rheumatic mitral stenosis. 2.Need for long-term OAC for a reason other than AF. 3.LA/LAA thrombus on TEE or ECG-gated contrast CT within 60 days before enrollment. 4.Ischemic stroke, systemic embolism, or ISTH major bleeding within 6 months. 5.Active significant bleeding, absolute OAC contraindication, or inability to continue OAC until postoperative imaging. 6.LVEF 3 months, or OAC plus DAPT, within 12 months. 15.Planned cardiac/thoracic surgery or percutaneous/surgical LAA closure within 12 months. 16.Participation in another interventional study/trial that may affect safety or endpoints. 17.Inability to complete scheduled visits/tests or 24-month follow-up. 18.Inability to undergo intraoperative TEE. 19.Any other condition considered inappropriate by the investigator. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 20 Day Anticipated trial start date - 2027 Year 01 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072127

Disclaimer: Curated by HT Syndication.