Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059696) titled 'Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation' on Nov. 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Tohoku Medical and Pharmaceutical University

Condition: Condition - Atrial Fibrillation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In patients with persistent atrial fibrillation undergoing catheter ablation, this study aims to determine whether identifying and ablating atrial fibrillation substrates based on focal trigger activity and frequency analysis can improve clinical outcomes. Patients will be randomly assigned to either an ablation (energy delivery) group or a non-ablation group to compare the efficacy and safety of the two strategies. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis Interventions/Control_2 - no ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Patients diagnosed with non-valvular persistent atrial fibrillation who are able to attend regular outpatient visits. (2) Patients aged 20 years or older at the time of obtaining consent (regardless of sex). (3) Patients who have provided written informed consent. Key exclusion criteria - (1) Patients with a confirmed diagnosis of mitral stenosis. (2) Patients with prosthetic heart valves (mechanical or bioprosthetic). (3) Patients who have experienced a cardiovascular event (stroke, myocardial infarction, non-infarction cardiac intervention, or heart failure requiring hospitalization) or bleeding requiring hospitalization within one month prior to enrollment. (4) Patients diagnosed with a life expectancy of less than one year due to any disease. (5) Patients with left atrial thrombus. (6) Patients with a left atrial diameter greater than 55 mm. (7) Patients with a history of catheter ablation. (8) Patients unable to continue anticoagulant therapy. (9) Pregnant patients. (10) Patients with thyroid dysfunction requiring treatment. (11) Patients with active malignancy. (12) Patients deemed unsuitable for participation in the study by the attending physician. Target Size - 147

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 03 Month 31 Day Date of IRB - 2025 Year 03 Month 31 Day Anticipated trial start date - 2025 Year 03 Month 31 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068281

Disclaimer: Curated by HT Syndication.