[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100327687":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":218,"collaborators":21,"id":220,"slug":221,"hasResults":222,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":21,"eligibilityCriteria":226,"healthyVolunteers":222,"sex":227,"minAge":228,"maxAge":21,"enrollmentInfo":229,"targetDuration":21,"studyType":232,"phases":233,"briefSummary":235,"conditions":236,"keywords":21,"overallStatus":79,"whyStopped":21,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},{"fullName":5,"class":6},"Medtronic Cardiac Surgery","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Cohort","EXPERIMENTAL","Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery",[13,14],"Procedure: Surgical Ablation","Device: Cardioblate and Cryoflex hand held devices",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Surgical Ablation","In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DEVICE","Cardioblate and Cryoflex hand held devices","The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.",[9],[28],{"name":29,"affiliation":30,"role":31},"Ralph J Damiano, MD","Washington University School of Medicine","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":21,"email":37},"Stephanie Yong","CONTACT","763-526-2032","stephanie.yong@medtronic.com",{"name":39,"role":35,"phone":40,"phoneExt":21,"email":41},"Jessica Halverson","763-514-9765","Jessica.halverson@medtronic.com",[43,57,67,77,92,106,120,132,142,156,165,175,185,199,209],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":21},"Stanford Hospitals and Clinic","COMPLETED","Palo Alto","California","94304","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.14302,37.44188,{"lat":55,"lon":54},{"facility":58,"status":59,"city":60,"state":47,"zip":61,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":21},"Adventist Health St. Helena","WITHDRAWN","St. Helena","94574",{"type":52,"coordinates":63},[64,65],-122.47026,38.50519,{"lat":65,"lon":64},{"facility":68,"status":45,"city":69,"state":70,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":21},"Hartford Healthcare","Hartford","Connecticut","06102",{"type":52,"coordinates":73},[74,75],-72.68509,41.76371,{"lat":75,"lon":74},{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":49,"countryCode":50,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"St Vincent Heart Center of Indiana","RECRUITING","Indianapolis","Indiana","46290",{"type":52,"coordinates":84},[85,86],-86.15804,39.76838,{"lat":86,"lon":85},[89],{"name":90,"role":35,"phone":21,"phoneExt":21,"email":91},"David Heimansohn, MD","heimansohn@mac.com",{"facility":93,"status":79,"city":94,"state":95,"zip":96,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":52,"coordinates":98},[99,100],-71.05977,42.35843,{"lat":100,"lon":99},[103],{"name":104,"role":35,"phone":21,"phoneExt":21,"email":105},"Serguei Melnitchouk, MD","smelnitchouk@mgh.harvard.edu",{"facility":107,"status":79,"city":108,"state":109,"zip":110,"country":49,"countryCode":50,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Corewell Health","Grand Rapids","Michigan","49503",{"type":52,"coordinates":112},[113,114],-85.66809,42.96336,{"lat":114,"lon":113},[117],{"name":118,"role":35,"phone":21,"phoneExt":21,"email":119},"Edward Murphy, MD","edward.murphy@spectrumhealth.org",{"facility":30,"status":79,"city":121,"state":122,"zip":123,"country":49,"countryCode":50,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"St Louis","Missouri","63110",{"type":52,"coordinates":125},[126,127],-90.19789,38.62727,{"lat":127,"lon":126},[130],{"name":29,"role":35,"phone":21,"phoneExt":21,"email":131},"damianor@wustl.edu",{"facility":133,"status":45,"city":134,"state":135,"zip":136,"country":49,"countryCode":50,"cosmosGeoPoint":137,"geoPoint":141,"contacts":21},"ProMedica Toledo","Toledo","Ohio","43606",{"type":52,"coordinates":138},[139,140],-83.55521,41.66394,{"lat":140,"lon":139},{"facility":143,"status":79,"city":144,"state":145,"zip":146,"country":49,"countryCode":50,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"type":52,"coordinates":148},[149,150],-79.99589,40.44062,{"lat":150,"lon":149},[153],{"name":154,"role":35,"phone":21,"phoneExt":21,"email":155},"Stephen Bailey, MD","stephen.bailey@ahn.org",{"facility":157,"status":45,"city":158,"state":145,"zip":159,"country":49,"countryCode":50,"cosmosGeoPoint":160,"geoPoint":164,"contacts":21},"Lankenau Medical Center","Wynnewood","19096",{"type":52,"coordinates":161},[162,163],-75.27074,40.00289,{"lat":163,"lon":162},{"facility":166,"status":45,"city":167,"state":168,"zip":169,"country":49,"countryCode":50,"cosmosGeoPoint":170,"geoPoint":174,"contacts":21},"Intermountain Medical Center","Murray","Utah","84107",{"type":52,"coordinates":171},[172,173],-111.88799,40.66689,{"lat":173,"lon":172},{"facility":176,"status":45,"city":177,"state":178,"zip":179,"country":49,"countryCode":50,"cosmosGeoPoint":180,"geoPoint":184,"contacts":21},"Sentara Norfolk General Hospital","Norfolk","Virginia","23507",{"type":52,"coordinates":181},[182,183],-76.28522,36.84681,{"lat":183,"lon":182},{"facility":186,"status":79,"city":187,"state":188,"zip":189,"country":49,"countryCode":50,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Virginia Mason Heart Institute","Seattle","Washington","98101",{"type":52,"coordinates":191},[192,193],-122.33207,47.60621,{"lat":193,"lon":192},[196],{"name":197,"role":35,"phone":21,"phoneExt":21,"email":198},"Robert Moraca, MD","Bob.Moraca@Virginiamason.org",{"facility":200,"status":79,"city":187,"state":188,"zip":201,"country":49,"countryCode":50,"cosmosGeoPoint":202,"geoPoint":204,"contacts":205},"Swedish Medical Center","98122",{"type":52,"coordinates":203},[192,193],{"lat":193,"lon":192},[206],{"name":207,"role":35,"phone":21,"phoneExt":21,"email":208},"Eric Lehr, MD","Eric.Lehr@swedish.org",{"facility":210,"status":59,"city":211,"state":188,"zip":212,"country":49,"countryCode":50,"cosmosGeoPoint":213,"geoPoint":217,"contacts":21},"St. Joseph Medical Center","Tacoma","98405",{"type":52,"coordinates":214},[215,216],-122.44429,47.25288,{"lat":216,"lon":215},{"type":219,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100327687","medtronic-terminate-af-study-100327687",false,"NCT03546374","Medtronic Terminate AF Study","Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)","Inclusion Criteria:\n\n* History of non-paroxysmal AF (persistent or longstanding persistent)\n* Concomitant indication for non-emergent open-heart surgery, eg,\n\n  1. Coronary artery bypass grafting\n  2. Valve repair or replacement\n* Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)\n\nExclusion Criteria:\n\n* Wolff-Parkinson-White syndrome\n* New York Heart Association (NYHA) Class = IV\n* Left Ventricular Ejection Fraction ≤ 30%\n* Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery\n* Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure\n* Contraindication for anticoagulation therapy\n* Left atrial diameter \\> 6.0 cm\n* Preoperative need for an intra-aortic balloon pump or intravenous inotropes\n* Renal failure requiring dialysis or hepatic failure\n* Life expectancy of less than 1 year\n* Predicted risk of operative mortality \\>10% as assessed by STS Risk Calculator\n* Pregnancy or desire to be pregnant within 12 months of the study treatment\n* Current diagnosis of active systemic infection\n* Active endocarditis\n* Documented MI 30 days prior to study enrollment\n* Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias","ALL","18 Years",{"count":230,"type":231},160,"ESTIMATED","INTERVENTIONAL",[234],"NA","The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).",[237,238],"Persistent Atrial Fibrillation","Longstanding Persistent Atrial Fibrillation","2026-05-07",{"date":241,"type":242},"2026-05-14","ACTUAL",{"date":244,"type":242},"2018-11-15",{"date":246,"type":231},"2026-12",{"name":5,"class":6},15]