[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610434":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":219,"collaborators":19,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":223,"sex":229,"minAge":230,"maxAge":19,"enrollmentInfo":231,"targetDuration":19,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Biosense Webster, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator","EXPERIMENTAL","Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.",[13],"Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Biosense Webster, Inc. 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Montefiore Medical Center","The Bronx","New York","10467",{"type":40,"coordinates":157},[158,159],-73.86641,40.84985,{"lat":159,"lon":158},{"facility":162,"status":33,"city":163,"state":164,"zip":165,"country":37,"countryCode":38,"cosmosGeoPoint":166,"geoPoint":170,"contacts":19},"Springfield Medical Center","Springfield","Ohio","45504",{"type":40,"coordinates":167},[168,169],-83.80882,39.92423,{"lat":169,"lon":168},{"facility":172,"status":33,"city":173,"state":174,"zip":175,"country":37,"countryCode":38,"cosmosGeoPoint":176,"geoPoint":180,"contacts":19},"Texas Cardiac Arrhythmia Research Foundation","Austin","Texas","78705",{"type":40,"coordinates":177},[178,179],-97.74306,30.26715,{"lat":179,"lon":178},{"facility":182,"status":33,"city":183,"state":174,"zip":184,"country":37,"countryCode":38,"cosmosGeoPoint":185,"geoPoint":189,"contacts":19},"Baylor Scott and White Research Institute","Fort Worth","76104",{"type":40,"coordinates":186},[187,188],-97.32085,32.72541,{"lat":188,"lon":187},{"facility":191,"status":33,"city":192,"state":174,"zip":193,"country":37,"countryCode":38,"cosmosGeoPoint":194,"geoPoint":198,"contacts":19},"Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano","Plano","75093",{"type":40,"coordinates":195},[196,197],-96.69889,33.01984,{"lat":197,"lon":196},{"facility":200,"status":33,"city":201,"state":202,"zip":203,"country":37,"countryCode":38,"cosmosGeoPoint":204,"geoPoint":208,"contacts":19},"Winchester Medical Center","Winchester","Virginia","22601",{"type":40,"coordinates":205},[206,207],-78.16333,39.18566,{"lat":207,"lon":206},{"facility":210,"status":33,"city":211,"state":212,"zip":213,"country":37,"countryCode":38,"cosmosGeoPoint":214,"geoPoint":218,"contacts":19},"Mercy Hospital","Janesville","Wisconsin","53548",{"type":40,"coordinates":215},[216,217],-89.01872,42.68279,{"lat":217,"lon":216},{"type":220,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100610434","a-study-assessing-long-term-safety-and-effectiveness-in-treatment-management-of-atrial-fibrillation-with-varipulse-catheter-system-100610434",false,"NCT07227532","A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System","Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System","AdmIREPAS","Inclusion Criteria:\n\n* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF\n* Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I\u002FIII antiarrhythmic drugs (AAD)\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)\n* Previous surgical or catheter ablation for AF\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF\n* Current enrollment in an investigational study evaluating another device or drug\n* Life expectancy less than 12 months\n* Any contraindications as defined in the Protocol","ALL","22 Years",{"count":232,"type":233},276,"ESTIMATED","INTERVENTIONAL",[236],"NA","The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).",[239],"Atrial Fibrillation","2026-06-04",{"date":242,"type":243},"2026-06-05","ACTUAL",{"date":245,"type":243},"2025-10-21",{"date":247,"type":233},"2030-12-31",{"name":5,"class":6},19]