[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610434":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":31,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":235,"collaborators":17,"id":237,"slug":17,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":238,"sex":244,"minAge":245,"maxAge":17,"enrollmentInfo":246,"targetDuration":17,"studyType":249,"phases":250,"briefSummary":251,"conditions":252,"keywords":17,"overallStatus":49,"whyStopped":17,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"Biosense Webster, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure","PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade\u002Fperforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke\u002Fcerebrovascular accident (CVA), major vascular access complication\u002Fbleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury\u002Fgastroparesis.","Within 7 days post index procedure",{"measure":14,"description":15,"timeFrame":16},"Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes","Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \\[AF\\], atrial tachycardia \\[AT\\] or atrial flutter \\[AFL\\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.","Day 61-1095 post-index procedure",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"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.",[30],"Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator",[32],{"type":33,"name":26,"description":34,"armGroupLabels":35,"otherNames":17},"DEVICE","Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.",[26],[37],{"name":38,"affiliation":5,"role":39},"Biosense Webster, Inc. Clinical Trial","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":17,"email":45},"Emily Purcell","CONTACT","+1 949 230 3701","EPurcel1@its.jnj.com",[47,61,70,80,90,99,108,118,127,137,147,157,167,177,187,197,206,215,225],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":17},"Phoenix Cardiovascular Research Group","RECRUITING","Phoenix","Arizona","85018","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-112.07404,33.44838,{"lat":59,"lon":58},{"facility":62,"status":49,"city":63,"state":51,"zip":64,"country":53,"countryCode":54,"cosmosGeoPoint":65,"geoPoint":69,"contacts":17},"Tucson Medical Center Pima Heart and Vascular","Tucson","85704",{"type":56,"coordinates":66},[67,68],-110.92648,32.22174,{"lat":68,"lon":67},{"facility":71,"status":49,"city":72,"state":73,"zip":74,"country":53,"countryCode":54,"cosmosGeoPoint":75,"geoPoint":79,"contacts":17},"OC Memorial","Fountain Valley","California","92708",{"type":56,"coordinates":76},[77,78],-117.95367,33.70918,{"lat":78,"lon":77},{"facility":81,"status":82,"city":83,"state":73,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":17},"San Diego Cardiac Center","WITHDRAWN","San Diego","92123",{"type":56,"coordinates":86},[87,88],-117.16472,32.71571,{"lat":88,"lon":87},{"facility":91,"status":82,"city":92,"state":73,"zip":93,"country":53,"countryCode":54,"cosmosGeoPoint":94,"geoPoint":98,"contacts":17},"Stanford Hospital and Clinics","Stanford","94305",{"type":56,"coordinates":95},[96,97],-122.16608,37.42411,{"lat":97,"lon":96},{"facility":100,"status":49,"city":101,"state":73,"zip":102,"country":53,"countryCode":54,"cosmosGeoPoint":103,"geoPoint":107,"contacts":17},"Community Memorial Hospital","Ventura","93003",{"type":56,"coordinates":104},[105,106],-119.29317,34.27834,{"lat":106,"lon":105},{"facility":109,"status":49,"city":110,"state":111,"zip":112,"country":53,"countryCode":54,"cosmosGeoPoint":113,"geoPoint":117,"contacts":17},"Aurora Denver Cardiology Associates","Aurora","Colorado","80012",{"type":56,"coordinates":114},[115,116],-104.83192,39.72943,{"lat":116,"lon":115},{"facility":119,"status":82,"city":120,"state":111,"zip":121,"country":53,"countryCode":54,"cosmosGeoPoint":122,"geoPoint":126,"contacts":17},"Colorado Heart and Vascular PC","Golden","80401",{"type":56,"coordinates":123},[124,125],-105.2211,39.75554,{"lat":125,"lon":124},{"facility":128,"status":49,"city":129,"state":130,"zip":131,"country":53,"countryCode":54,"cosmosGeoPoint":132,"geoPoint":136,"contacts":17},"Orlando Health Heart and Vascular Institute","Orlando","Florida","32806",{"type":56,"coordinates":133},[134,135],-81.37924,28.53834,{"lat":135,"lon":134},{"facility":138,"status":82,"city":139,"state":140,"zip":141,"country":53,"countryCode":54,"cosmosGeoPoint":142,"geoPoint":146,"contacts":17},"Deaconess Gateway Hospital","Newburgh","Indiana","47630",{"type":56,"coordinates":143},[144,145],-87.40529,37.94449,{"lat":145,"lon":144},{"facility":148,"status":49,"city":149,"state":150,"zip":151,"country":53,"countryCode":54,"cosmosGeoPoint":152,"geoPoint":156,"contacts":17},"The Kansas City Heart Rhythm Institute","Overland Park","Kansas","66211",{"type":56,"coordinates":153},[154,155],-94.67079,38.98223,{"lat":155,"lon":154},{"facility":158,"status":49,"city":159,"state":160,"zip":161,"country":53,"countryCode":54,"cosmosGeoPoint":162,"geoPoint":166,"contacts":17},"Trinity Health","Ypsilanti","Michigan","48197",{"type":56,"coordinates":163},[164,165],-83.61299,42.24115,{"lat":165,"lon":164},{"facility":168,"status":49,"city":169,"state":170,"zip":171,"country":53,"countryCode":54,"cosmosGeoPoint":172,"geoPoint":176,"contacts":17},"Albert Einstein College Of Medicine - Montefiore Medical Center","The Bronx","New York","10467",{"type":56,"coordinates":173},[174,175],-73.86641,40.84985,{"lat":175,"lon":174},{"facility":178,"status":49,"city":179,"state":180,"zip":181,"country":53,"countryCode":54,"cosmosGeoPoint":182,"geoPoint":186,"contacts":17},"Springfield Medical Center","Springfield","Ohio","45504",{"type":56,"coordinates":183},[184,185],-83.80882,39.92423,{"lat":185,"lon":184},{"facility":188,"status":49,"city":189,"state":190,"zip":191,"country":53,"countryCode":54,"cosmosGeoPoint":192,"geoPoint":196,"contacts":17},"Texas Cardiac Arrhythmia Research Foundation","Austin","Texas","78705",{"type":56,"coordinates":193},[194,195],-97.74306,30.26715,{"lat":195,"lon":194},{"facility":198,"status":49,"city":199,"state":190,"zip":200,"country":53,"countryCode":54,"cosmosGeoPoint":201,"geoPoint":205,"contacts":17},"Baylor Scott and White Research Institute","Fort Worth","76104",{"type":56,"coordinates":202},[203,204],-97.32085,32.72541,{"lat":204,"lon":203},{"facility":207,"status":49,"city":208,"state":190,"zip":209,"country":53,"countryCode":54,"cosmosGeoPoint":210,"geoPoint":214,"contacts":17},"Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano","Plano","75093",{"type":56,"coordinates":211},[212,213],-96.69889,33.01984,{"lat":213,"lon":212},{"facility":216,"status":49,"city":217,"state":218,"zip":219,"country":53,"countryCode":54,"cosmosGeoPoint":220,"geoPoint":224,"contacts":17},"Winchester Medical Center","Winchester","Virginia","22601",{"type":56,"coordinates":221},[222,223],-78.16333,39.18566,{"lat":223,"lon":222},{"facility":226,"status":49,"city":227,"state":228,"zip":229,"country":53,"countryCode":54,"cosmosGeoPoint":230,"geoPoint":234,"contacts":17},"Mercy Hospital","Janesville","Wisconsin","53548",{"type":56,"coordinates":231},[232,233],-89.01872,42.68279,{"lat":233,"lon":232},{"type":236,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":247,"type":248},276,"ESTIMATED","INTERVENTIONAL",[19],"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).",[253],"Atrial Fibrillation","2026-06-04",{"date":256,"type":257},"2026-06-05","ACTUAL",{"date":259,"type":257},"2025-10-21",{"date":261,"type":248},"2030-12-31",{"name":5,"class":6},19]