[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560512":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":32,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":320,"collaborators":17,"id":322,"slug":17,"hasResults":323,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":17,"eligibilityCriteria":327,"healthyVolunteers":323,"sex":328,"minAge":329,"maxAge":17,"enrollmentInfo":330,"targetDuration":17,"studyType":333,"phases":17,"briefSummary":334,"conditions":335,"keywords":17,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":346},{"fullName":5,"class":6},"Medtronic Cardiac Ablation Solutions","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Efficacy-Freedom from Atrial Fibrillation","Estimate the 36-month freedom from AF\u002FAFL\u002FAT recurrence following ablation using the PulseSelect™ PFA system.","36-months after the index ablation procedure",{"measure":14,"description":15,"timeFrame":16},"Safety- Freedom from Device\u002FProcedure Related Adverse Events","Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.","6 months post-ablation]",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.","Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"Paroxysmal","Ablation using the PulseSelect™ PFA system",[28],"Device: PulseSelect™ PFA system",{"label":30,"type":17,"description":26,"interventionNames":31},"Persistent",[28],[33],{"type":34,"name":35,"description":26,"armGroupLabels":36,"otherNames":17},"DEVICE","PulseSelect™ PFA system",[25,30],[38],{"name":39,"affiliation":40,"role":41},"Khaldoun Tarakji, MD","Medtronic CAS Chief Medical Officer","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":17,"email":47},"Josman Suri","CONTACT","7635050262","josman.suri@medtronic.com",[49,68,89,109,124,139,150,164,178,189,203,218,232,246,261,276,290,305],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of South Florida Health (USF)","RECRUITING","Tampa","Florida","33606-3603","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-82.45843,27.94752,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":17,"email":67},"David Wilson","(813) 821-8001","dwilson2@usf.edu",{"facility":69,"status":51,"city":70,"state":71,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Piedmont Heart Institute","Atlanta","Georgia","30309",{"type":58,"coordinates":74},[75,76],-84.38798,33.749,{"lat":76,"lon":75},[79,83,86],{"name":80,"role":45,"phone":81,"phoneExt":17,"email":82},"Reza Karimianpour","4046052800","reza.karimianpour@piedmont.org",{"name":84,"role":45,"phone":17,"phoneExt":17,"email":85},"Megan Kopp","megan.kopp@piedmont.org",{"name":87,"role":88,"phone":17,"phoneExt":17,"email":17},"Reza Karimianpour, DO","PRINCIPAL_INVESTIGATOR",{"facility":90,"status":51,"city":91,"state":92,"zip":93,"country":55,"countryCode":56,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Endeavor Health Swedish Hospital","Chicago","Illinois","60625",{"type":58,"coordinates":95},[96,97],-87.65005,41.85003,{"lat":97,"lon":96},[100,104,108],{"name":101,"role":45,"phone":102,"phoneExt":17,"email":103},"Hany Demo, MD","3472160095","hanydemo@gmail.com",{"name":105,"role":45,"phone":106,"phoneExt":17,"email":107},"Marisa Durante","8475036454","mdurante@northshore.org",{"name":101,"role":88,"phone":17,"phoneExt":17,"email":17},{"facility":110,"status":51,"city":111,"state":112,"zip":113,"country":55,"countryCode":56,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Pikeville Medical Center","Whitesburg","Kentucky","41858-7428",{"type":58,"coordinates":115},[116,117],-82.82683,37.11843,{"lat":117,"lon":116},[120],{"name":121,"role":45,"phone":122,"phoneExt":17,"email":123},"Joseph Souza, MD","(828) 274-6000","joseph.souza@pikevillehospital.org",{"facility":125,"status":51,"city":126,"state":127,"zip":128,"country":55,"countryCode":56,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Southcoast Health System","Fall River","Massachusetts","02720",{"type":58,"coordinates":130},[131,132],-71.15505,41.70149,{"lat":132,"lon":131},[135],{"name":136,"role":45,"phone":17,"phoneExt":137,"email":138},"Nitesh Sood, MD","(508) 973-7328","soodn@southcoast.org",{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":55,"countryCode":56,"cosmosGeoPoint":145,"geoPoint":149,"contacts":17},"Beaumont Health System","WITHDRAWN","Royal Oak","Michigan","48073",{"type":58,"coordinates":146},[147,148],-83.14465,42.48948,{"lat":148,"lon":147},{"facility":151,"status":51,"city":152,"state":153,"zip":154,"country":55,"countryCode":56,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Nebraska Medical Center","Omaha","Nebraska","68198",{"type":58,"coordinates":156},[157,158],-95.94043,41.25626,{"lat":158,"lon":157},[161],{"name":162,"role":45,"phone":17,"phoneExt":17,"email":163},"Jason Payne, MD","jason.payne@unmc.edu",{"facility":165,"status":51,"city":166,"state":166,"zip":167,"country":55,"countryCode":56,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"The Valley Hospital","New York","10025",{"type":58,"coordinates":169},[170,171],-74.00597,40.71427,{"lat":171,"lon":170},[174],{"name":175,"role":45,"phone":176,"phoneExt":17,"email":177},"Suneet Mittal, MD","(201) 432-7837","mittsu@valleyhealth.com",{"facility":179,"status":51,"city":166,"state":166,"zip":180,"country":55,"countryCode":56,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"Northwell Health Lenox Hill Hospital","10075",{"type":58,"coordinates":182},[170,171],{"lat":171,"lon":170},[185],{"name":186,"role":45,"phone":187,"phoneExt":17,"email":188},"Stavros Mountantonakis, MD","(212) 434-6500","smountanto@northwell.edu",{"facility":190,"status":51,"city":191,"state":192,"zip":193,"country":55,"countryCode":56,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Duke University Medical Center (DUMC)","Durham","North Carolina","27710",{"type":58,"coordinates":195},[196,197],-78.89862,35.99403,{"lat":197,"lon":196},[200],{"name":201,"role":45,"phone":202,"phoneExt":17,"email":17},"Kevin Jackson","(919) 684-8111",{"facility":204,"status":51,"city":205,"state":206,"zip":207,"country":55,"countryCode":56,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Bethesda North Hospital","Cincinnati","Ohio","45220",{"type":58,"coordinates":209},[210,211],-84.51439,39.12711,{"lat":211,"lon":210},[214],{"name":215,"role":45,"phone":216,"phoneExt":17,"email":217},"Gaurang Gandhi, MD","5137459800","gaurang_gandhi@trihealth.com",{"facility":219,"status":51,"city":220,"state":206,"zip":221,"country":55,"countryCode":56,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"The Ohio State University Wexner Medical Center","Columbus","045218",{"type":58,"coordinates":223},[224,225],-82.99879,39.96118,{"lat":225,"lon":224},[228],{"name":229,"role":45,"phone":230,"phoneExt":17,"email":231},"John Hummel","(614) 293-4967","john.hummel@osumc.edu",{"facility":233,"status":51,"city":234,"state":206,"zip":235,"country":55,"countryCode":56,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Mount Carmel Grove City Medical Center","Grove City","43123",{"type":58,"coordinates":237},[238,239],-83.09296,39.88145,{"lat":239,"lon":238},[242],{"name":243,"role":45,"phone":244,"phoneExt":17,"email":245},"Jianqing Li, MD","(614) 627-2000","jianqing.li@mchs.com",{"facility":247,"status":51,"city":248,"state":249,"zip":250,"country":55,"countryCode":56,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Doylestown Health Cardiology a division of Doylestown Health Physicians","Doylestown","Pennsylvania","18901-2554",{"type":58,"coordinates":252},[253,254],-75.12989,40.31011,{"lat":254,"lon":253},[257],{"name":258,"role":45,"phone":259,"phoneExt":17,"email":260},"Robert Sangrigoli, MD","267-893-6800","rsangrigoli@dh.org",{"facility":262,"status":51,"city":263,"state":264,"zip":265,"country":55,"countryCode":56,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"AnMed Health Center","Anderson","South Carolina","29621",{"type":58,"coordinates":267},[268,269],-82.65013,34.50344,{"lat":269,"lon":268},[272],{"name":273,"role":45,"phone":274,"phoneExt":17,"email":275},"Rick Henderson, MD","(336) 716-8636","rick.henderson1@anmedhealth.org",{"facility":277,"status":51,"city":278,"state":264,"zip":279,"country":55,"countryCode":56,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Medical University of South Carolina (MUSC)","Charleston","29425-8908",{"type":58,"coordinates":281},[282,283],-79.93275,32.77632,{"lat":283,"lon":282},[286],{"name":287,"role":45,"phone":288,"phoneExt":17,"email":289},"Rachel Kaplan, MD","(843) 792-2300","kaplanra@musc.edu",{"facility":291,"status":51,"city":292,"state":293,"zip":294,"country":55,"countryCode":56,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Texas Health Research & Education Institute","Dallas","Texas","75231-3815",{"type":58,"coordinates":296},[297,298],-96.80667,32.78306,{"lat":298,"lon":297},[301],{"name":302,"role":45,"phone":303,"phoneExt":17,"email":304},"Charles Lampe, MD","(214) 915-0507","charleslampe@texashealth.org",{"facility":306,"status":51,"city":307,"state":308,"zip":309,"country":55,"countryCode":56,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"University of Virginia Medical Center","Charlottesville","Virginia","22908",{"type":58,"coordinates":311},[312,313],-78.47668,38.02931,{"lat":313,"lon":312},[316],{"name":317,"role":45,"phone":318,"phoneExt":17,"email":319},"Michael Mangrum, MD","(434) 924-3817","jmm5v@virginia.edu",{"type":321,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100560512",false,"NCT06578104","PULSED AF Post-Approval Study","PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry","Inclusion Criteria\n\n* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF\n* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)\n* Patient is ≥ 18 years of age\n* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System\n* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria\n\n* Long-standing persistent AF (continuous AF sustained \\>12 months)\n* Prior left atrial catheter or surgical ablation\n* Patient with life expectancy \\\u003C 36 months\n* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager","ALL","18 Years",{"count":331,"type":332},580,"ESTIMATED","OBSERVATIONAL","PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.",[336],"Atrial Fibrillation","2026-05-22",{"date":339,"type":340},"2026-05-27","ACTUAL",{"date":342,"type":340},"2024-11-04",{"date":344,"type":332},"2029-06-01",{"name":5,"class":6},18]