{"title":"InsightPFA试验的基本原理和设计：一项前瞻性、多中心、随机对照试验，比较不可逆电穿孔脉冲场消融与射频消融在中国症状性阵发性心房颤动患者中的疗效。","authors":"Weidong Lin, Sijia Pu, Huimin Chu, Dong Chang, Xiaomeng Yin, Yuegang Wang, Yizhou Xu, Shaolong Li, Jian Yang, Wenqing Zhu, Songnan Li, Weidong Gao, Yanbo Chen, Dong Xu, Chenyang Jiang, Yumei Xue","doi":"10.1111/jce.16573","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.</p>\n </section>\n \n <section>\n \n <h3> Methods and Results</h3>\n \n <p>The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.</p>\n \n <p><b>Trial Registration:</b> https://www.clinicaltrials.gov/study/NCT06014996; NCT06014996.</p>\n </section>\n </div>","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":"36 3","pages":"632-641"},"PeriodicalIF":2.3000,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation\",\"authors\":\"Weidong Lin, Sijia Pu, Huimin Chu, Dong Chang, Xiaomeng Yin, Yuegang Wang, Yizhou Xu, Shaolong Li, Jian Yang, Wenqing Zhu, Songnan Li, Weidong Gao, Yanbo Chen, Dong Xu, Chenyang Jiang, Yumei Xue\",\"doi\":\"10.1111/jce.16573\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods and Results</h3>\\n \\n <p>The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.</p>\\n \\n <p><b>Trial Registration:</b> https://www.clinicaltrials.gov/study/NCT06014996; NCT06014996.</p>\\n </section>\\n </div>\",\"PeriodicalId\":15178,\"journal\":{\"name\":\"Journal of Cardiovascular Electrophysiology\",\"volume\":\"36 3\",\"pages\":\"632-641\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-01-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiovascular Electrophysiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/jce.16573\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular Electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jce.16573","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation
Background
Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.
Methods and Results
The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.
Conclusions
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
期刊介绍：
Journal of Cardiovascular Electrophysiology (JCE) keeps its readership well informed of the latest developments in the study and management of arrhythmic disorders. Edited by Bradley P. Knight, M.D., and a distinguished international editorial board, JCE is the leading journal devoted to the study of the electrophysiology of the heart.
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