[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535247":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":70,"collaborators":27,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":27,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":27,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"PROMISED","EXPERIMENTAL","Guided by a circular mapping catheter, all patients initially underwent wide-area circumferential pulmonary vein isolation (CPVI) using radiofrequency ablation catheter. If sinus rhythm was restored after performing the CPVI ablation, the ablation procedure would be stopped. If AF persisted, patients underwent linear ablation (roof linear ablation+anterior septal linear ablation+mitral isthmus linear ablation) using radiofrequency ablation catheter. Then, guided by left atrial appendage (LAA) angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology.\n\nInterventions:\n\nProcedure: CPVI+ roof linear ablation + anterior septal linear ablation + mitral isthmus linear ablation + Left atrial appendage closure (LAAC)",[13,14,15],"Procedure: PROMISED","Device: Radiofrequency ablation catheter","Device: left atrial appendage occlusion device",{"label":17,"type":18,"description":19,"interventionNames":20},"CPVI and LAAC","ACTIVE_COMPARATOR","Guided by a circular mapping catheter, all patients initially underwent wide-area CPVI using radiofrequency ablation catheter. Then, guided by LAA angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology.\n\nInterventions:\n\nProcedure: CPVI and LAAC",[21,14,15],"Procedure: CPVI and LAAC",[23,28,31,36],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","CPVI: Achievement of a wide disconnection of the right and left pulmonary veins; Roof linear ablation: linear ablation in the left atria roof; Anterior septal linear ablation: linear ablation in the anterior septal linear which coursed from the middle of the right superior and inferior pulmonary veins or the middle of the right superior pulmonary vein to the mitral valve annulus; Mitral isthmus linear ablation: linear ablation in the mitral isthmus; Left atrial appendage closure: Occlusion of the left atrial appendage with a left atrial appendage occlusion device.",[9],null,{"type":24,"name":17,"description":29,"armGroupLabels":30,"otherNames":27},"CPVI: Achievement of a wide disconnection of the right and left pulmonary veins; Left atrial appendage closure: Occlusion of the left atrial appendage with a left atrial appendage occlusion device.",[17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"DEVICE","Radiofrequency ablation catheter","Device： Radiofrequency ablation catheter",[17,9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"left atrial appendage occlusion device","Device： left atrial appendage occlusion device",[17,9],[41],{"name":42,"affiliation":5,"role":43},"Yue-chun Li, MD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","+86-0577-8567-6610","liyuechun1980@sina.com",{"name":50,"role":46,"phone":47,"phoneExt":27,"email":51},"Yuan-nan Lin, MD","597049712@qq.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University","RECRUITING","Wenzhou","Zhejiang","325000","China","CN",{"type":62,"coordinates":63},"Point",[64,65],120.66682,27.99942,{"lat":65,"lon":64},[68,69],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},{"name":50,"role":46,"phone":47,"phoneExt":27,"email":51},{"type":71,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100535247","left-roof-linear-mitral-isthmus-linear-and-left-anterior-septal-linear-ablation-for-non-paroxysmal-af-promised-trial-100535247",false,"NCT06249347","Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.","Pulmonary Vein Isolation and Left Roof Linear, Mitral Isthmus Linear, and Left Anterior Septal Linear Ablation, and Left Atrial Appendage Device Occlusion in Patients With Non-paroxysmal Atrial Fibrillation: PROMISED Trial.","Inclusion criteria:\n\n1. Age \\> 18 years;\n2. Persistent AF (AF duration \\> 7 days);\n3. CHA2DS2-VASc score ≥2;\n4. Presence of at least one of the following conditions:\n\n   * Unsuitable for long-term standardized anticoagulation therapy;\n   * Stroke or embolism still occurred based on long-term standardized anticoagulation therapy;\n   * HAS-BLED score ≥3;\n   * Unwillingness for long-term anticoagulation therapy;\n\nExclusion Criteria:\n\n1. Previous atrial fibrillation ablation\n2. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;\n3. persistent AF that lasts \\>10 years\n4. Scheduled cardiac surgical intervention.\n5. Documented left atrial thrombus\u002F left atrial appendage thrombus or another abnormality that precludes catheter\u002FLAAC introduction\n6. Life expectancy less than 1 year","ALL","18 Years",{"count":82,"type":83},166,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.",[89,90],"Atrial Fibrillation","Atrial Fibrillation, Persistent",[92,93,94,95],"non-paroxysmal atrial fibrillation","left atrial anterior wall ablation","roof linear ablation","mitral isthmus linear ablation","2024-02-08",{"date":98,"type":99},"2024-02-12","ACTUAL",{"date":101,"type":99},"2024-01-28",{"date":103,"type":83},"2026-12-31",{"name":5,"class":6},1]