Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060411) titled 'Tohoku Observational Study for Atrial Fibrillation Patients with Treatment by Pulse Field ablation Registry Study' on Jan. 21.

Study Type: Observational

Primary Sponsor: Institute - Tohoku Medical and Pharmaceutical University

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

Objective: Narrative objectives1 - The purpose of this study is to clarify the clinical usefulness and remaining challenges of pulse field ablation (PFA) catheters for atrial fibrillation by analyzing their effectiveness and safety following ablation procedures in a large-scale, regional multicenter registry across the Tohoku area. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old < Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Patients with a confirmed diagnosis of non-valvular atrial fibrillation who are able to attend outpatient follow-up visits. (2) Patients aged 20 years or older at the time of informed 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 valves). (3) Patients who experienced a cardiovascular event (stroke, myocardial infarction, nonmyocardial infarction cardiovascular intervention, or heart failure requiring hospitalization) or bleeding requiring hospitalization within 1 month prior to enrollment. (4) Patients with a life expectancy of less than 1 year due to any underlying disease. (5) Patients with left atrial thrombus. (6) Patients who are unable to continue oral anticoagulant therapy. (7) Pregnant patients. (8) Patients with active malignancy. (9) Patients who are otherwise deemed inappropriate for study participation by the attending physician. Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 28 Day Date of IRB - 2025 Year 11 Month 06 Day Anticipated trial start date - 2026 Year 01 Month 21 Day Last follow-up date - 2027 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069111

Disclaimer: Curated by HT Syndication.