{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T09:05:08Z","timestamp":1779959108168,"version":"3.53.1"},"reference-count":20,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T00:00:00Z","timestamp":1779926400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T00:00:00Z","timestamp":1779926400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pacing Clinical Electrophis"],"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n The variable\u2010loop circular catheter (VLCC) showed promising outcomes in European and US studies, but evidence is limited in Asian populations. afIRE trial assessed 12\u2010month safety and effectiveness of the VLCC in Chinese patients with symptomatic, drug\u2010refractory paroxysmal atrial fibrillation (AF).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n AfIRE was a prospective, multicenter, single\u2010arm trial for adults undergoing first\u2010time pulmonary vein isolation (PVI) with the VLCC. Primary effectiveness was 12\u2010month freedom from atrial arrhythmia recurrence (systematically assessed by electrocardiogram and Holter monitoring at 3\u2010, 6\u2010, and 12\u2010months post\u2010ablation or when symptomatic), repeat ablation, procedural failure, or Class I\/III antiarrhythmic drug use. Safety was defined by incidence of primary adverse events (PAEs).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Of 142 patients enrolled, 123 (mean age 57.0 years, 45.5% female) comprised the main\u2010stage cohort (patients treated with the VLCC after roll in). Median procedure, pulsed field ablation (PFA), and fluoroscopy times were 115.0, 36.1, and 5.0 min, respectively. Acute PVI was achieved in all patients, with 89.4% without acute reconnection and 11.4% undergoing non\u2010PV ablation. Twelve\u2010month primary effectiveness success and freedom from symptomatic recurrence were 74.8% and 87.0%, respectively. Safety was favorable, with PAEs in 2 patients (1.6%; vascular complications; unlikely device\u2010related). Multivariable analysis of the primary endpoint showed that preserved left ventricular ejection fraction (\u2265 60%) was associated with 86% reduction in odds of 12\u2010month atrial arrhythmia recurrence; diabetes, \u2265 9 symptomatic AF episodes, and < 48 valid PFA applications (16 ablations) numerically increased odds of recurrence.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n The first Asian VLCC experience demonstrated favorable 12\u2010month effectiveness and excellent safety, reinforcing reproducibility across global AF populations.<\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n NCT05552963<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/pace.70294","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T08:15:13Z","timestamp":1779956113000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["12\u2010Month Clinical Outcomes Using a Variable\u2010Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population"],"prefix":"10.1111","author":[{"given":"Hailong","family":"Tao","sequence":"first","affiliation":[{"name":"The First Affiliated Hospital of Zhengzhou University Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heng","family":"Cai","sequence":"additional","affiliation":[{"name":"Tianjin Medical University General Hospital Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Fu","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9469-1054","authenticated-orcid":false,"given":"Shaowen","family":"Liu","sequence":"additional","affiliation":[{"name":"Shanghai General Hospital Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6492-5702","authenticated-orcid":false,"given":"Songwen","family":"Chen","sequence":"additional","affiliation":[{"name":"Shanghai General Hospital Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lianjun","family":"Gao","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Dalian Medical University Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1897-7448","authenticated-orcid":false,"given":"Xiaomeng","family":"Yin","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Dalian Medical University Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7354-0014","authenticated-orcid":false,"given":"Yumei","family":"Xue","sequence":"additional","affiliation":[{"name":"Guangdong Provincial People's Hospital Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongtao","family":"Liao","sequence":"additional","affiliation":[{"name":"Guangdong Provincial People's Hospital Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8164-9183","authenticated-orcid":false,"given":"Rui","family":"Zeng","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaijun","family":"Cui","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianzeng","family":"Dong","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Zhengzhou University Zhengzhou China"},{"name":"Beijing Anzhen Hospital Capital Medical University Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,28]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"crossref","DOI":"10.1161\/JAHA.120.020163","article-title":"Trends in Cardiovascular Mortality Related to Atrial Fibrillation in the United States, 2011 to 2018","volume":"10","author":"Tanaka Y.","year":"2021","journal-title":"Journal of the American Heart Association"},{"key":"e_1_2_15_3_1","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1016\/j.cjco.2024.11.017","article-title":"Trends in Global Burden and Socioeconomic Profiles of Atrial Fibrillation and Atrial Flutter: Insights From the Global Burden of Disease Study 2021","volume":"7","author":"Tan S. 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W.","year":"2025","journal-title":"CJC Open"},{"key":"e_1_2_15_4_1","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1186\/s12872-025-05036-5","article-title":"Trends in United States Mortality Among Patients With Atrial Fibrillation\/Flutter Related Heart Failure (1999\u20102024): Disparities by Gender, Race\/Ethnicity and Region","volume":"25","author":"Rani S.","year":"2025","journal-title":"BMC Cardiovascular Disorders [Electronic Resource]"},{"key":"e_1_2_15_5_1","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1136\/heartjnl-2020-317915","article-title":"Atrial Fibrillation Prevalence, Awareness and Management in a Nationwide Survey of Adults in China","volume":"107","author":"Du X.","year":"2021","journal-title":"Heart"},{"key":"e_1_2_15_6_1","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/j.jacc.2023.08.017","article-title":"2023 ACC\/AHA\/ACCP\/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"83","author":"Members W. C.","year":"2024","journal-title":"Journal of the American College of Cardiology"},{"key":"e_1_2_15_7_1","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1055\/s-0041-1739411","article-title":"2021 Focused Update Consensus Guidelines of the Asia Pacific Heart Rhythm Society on Stroke Prevention in Atrial Fibrillation: Executive Summary","volume":"122","author":"Chao T. 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Y.","year":"2023","journal-title":"New England Journal of Medicine"},{"key":"e_1_2_15_13_1","doi-asserted-by":"crossref","DOI":"10.1093\/europace\/euae174","article-title":"Efficacy and Safety of a Novel Hexaspline Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation: The PLEASE\u2010AF Study","volume":"26","author":"Wang Z.","year":"2024","journal-title":"Europace"},{"key":"e_1_2_15_14_1","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1111\/pace.15162","article-title":"Feasibility and Safety of Pulsed\u2010Field Ablation for Persistent Atrial Fibrillation: A Prospective Study","volume":"48","author":"Chen G.","year":"2025","journal-title":"Pacing and Clinical Electrophysiology"},{"key":"e_1_2_15_15_1","article-title":"Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable\u2010Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3\u2010Dimensional Mapping System: 1\u2010Year Outcomes of the multicenter InspIRE Study","volume":"16","author":"Duytschaever M.","year":"2023","journal-title":"Circulation: Arrhythmia and Electrophysiology"},{"key":"e_1_2_15_16_1","article-title":"Predictors of Success for Pulmonary Vein Isolation With Pulsed\u2010Field Ablation Using a Variable\u2010Loop Catheter With 3D Mapping Integration: Complete 12\u2010Month Outcomes From InspIRE","volume":"17","author":"De Potter T.","year":"2024","journal-title":"Circulation: Arrhythmia and Electrophysiology"},{"key":"e_1_2_15_17_1","doi-asserted-by":"crossref","first-page":"1174","DOI":"10.1161\/CIRCULATIONAHA.124.070333","article-title":"Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Aafety and Effectiveness in the AdmIRE Pivotal Trial","volume":"150","author":"Reddy V. 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