[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100298716":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":13,"armGroups":42,"interventions":50,"overallOfficials":13,"centralContacts":61,"locations":67,"responsibleParty":131,"collaborators":13,"id":133,"slug":13,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":13,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":13,"enrollmentInfo":141,"targetDuration":13,"studyType":144,"phases":145,"briefSummary":146,"conditions":147,"keywords":13,"overallStatus":70,"whyStopped":13,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"CardioFocus","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter\u002Fatrial tachycardia (AFL\u002FAT) lasting longer than 30 seconds post the 90 day blanking period","The outcome will be assessed from 91 days post procedure through 12 months","Day 91 through 12 months",null,[15,19,22,25,28,32],{"measure":16,"description":17,"timeFrame":18},"Chronic Effectiveness","Freedom from symptomatic AF or symptomatic atypical AFL\u002FAT","36 months",{"measure":20,"description":21,"timeFrame":18},"Chronic Safety","Reporting of adverse events",{"measure":23,"description":24,"timeFrame":18},"Effect of Operator Experience on primary effectiveness endpoint","Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL\u002FAT",{"measure":26,"description":27,"timeFrame":18},"Effect of Operator Experience on primary safety endpoint","Assess relationship between operator experience and rate of Primary Adverse Events (PAE)",{"measure":29,"description":30,"timeFrame":31},"Safety Outcomes by Gender","Assess relationship between gender and rate of PAEs","12 months and 36 months",{"measure":33,"description":34,"timeFrame":18},"Neurological Events","Assess relationship between neurological events and procedural parameters",{"allocation":36,"interventionModel":37,"interventionModelDescription":13,"primaryPurpose":38,"observationalModel":13,"timePerspective":13,"maskingInfo":39},"NA","SINGLE_GROUP","TREATMENT",{"masking":40,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Treatment","OTHER","Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System",[48,49],"Device: HeartLight","Procedure: Ablation",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":13},"DEVICE","HeartLight","HeartLight Endoscopic Ablation System",[44],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":13},"PROCEDURE","Ablation","Pulmonary vein isolation ablation",[44],[62],{"name":63,"role":64,"phone":65,"phoneExt":13,"email":66},"Study Director","CONTACT","508-658-7253","lhausmann@cardiofocus.com",[68,86,99,114],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University of Arizona Sarver HeartCenter","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-110.92648,32.22174,{"lat":80,"lon":79},[83],{"name":84,"role":85,"phone":13,"phoneExt":13,"email":13},"Mathew Hutchinson, 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MD",{"facility":115,"status":70,"city":116,"state":117,"zip":118,"country":74,"countryCode":75,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"University Of Virginia Health System","Charlottesville","Virginia","22908",{"type":77,"coordinates":120},[121,122],-78.47668,38.02931,{"lat":122,"lon":121},[125,129],{"name":126,"role":64,"phone":127,"phoneExt":13,"email":128},"Mary Jane Strickland","434-982-6401","MJS7W@hscmail.mcc.virginia.edu",{"name":130,"role":85,"phone":13,"phoneExt":13,"email":13},"J. Michael Mangrum, MD",{"type":132,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100298716",false,"NCT03168659","CardioFocus HeartLight Post-Approval Study","Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation","Inclusion Criteria:\n\n* 18 years or older\n* planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation\n* failure of at least one anti-arrhythmic drug\n* others\n\nExclusion Criteria:\n\n* overall good health as established by multiple criteria","ALL","18 Years",{"count":142,"type":143},250,"ESTIMATED","INTERVENTIONAL",[36],"This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.",[148],"Atrial Fibrillation","2024-08-19",{"date":151,"type":152},"2024-08-20","ACTUAL",{"date":154,"type":152},"2017-06-16",{"date":156,"type":143},"2028-10",{"name":5,"class":6},4]