[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590869":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Kardium Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Globe Pulsed Field System","EXPERIMENTAL",null,[13],"Device: Globe Pulsed Field System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","Ablation and atrial mapping with the Globe Pulsed Field System",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Clinical Affairs","CONTACT","+1 (604) 248 8891","Clinical.Affairs@kardium.com",[26],{"facility":27,"status":28,"city":29,"state":11,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Westpfalz-Klinikum GmbH Kaiserslautern","RECRUITING","Kaiserslautern","67655","Germany","DE",{"type":34,"coordinates":35},"Point",[36,37],7.77161,49.443,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":11,"phoneExt":11,"email":11},"Westpfalz-Klinikum GmbH Kaiserslautern Hellmut-Hartert-Straße 1, Kaiserslautern, 67655, Germany","PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100590869","a-prospective-clinical-study-to-evaluate-the-safety-and-effectiveness-of-pulmonary-vein-isolation-plus-box-isolation-of-fibrotic-areas-with-the-globe-pulsed-field-system-for-treating-patients-with-symptomatic-paroxysmal-or-persistent-atrial-fibrillation-100590869",false,"NCT06973031","A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation","GLOBAL-PF","Key inclusion criteria:\n\n* A diagnosis of recurrent symptomatic paroxysmal or persistent AF\n* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III\n\nKey exclusion criteria:\n\n* Long-standing persistent AF (sustained \\>12 months)\n* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin\n* History of thromboembolic events within the past six months\n* Myocardial infarction (MI)\u002Fpercutaneous coronary intervention (PCI) within the last three months\n* Any cardiac surgery within the previous six months\n* Prior left atrial ablation or surgical procedure\n* Presence of an implanted cardiac device\n* Body mass index (BMI) \\>40 kg\u002Fm\\^2\n* Left ventricular ejection fraction (LVEF) \\\u003C35%\n* Anterior-posterior left atrial (LA) diameter \\>55mm","ALL","18 Years","80 Years",{"count":56,"type":57},115,"ESTIMATED","INTERVENTIONAL",[60],"NA","The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.",[63,64],"Paroxysmal Atrial Fibrillation (PAF)","Persistent Atrial Fibrillation",[66],"Pulsed Field Ablation","2025-06-13",{"date":69,"type":70},"2025-06-16","ACTUAL",{"date":72,"type":70},"2025-06-10",{"date":74,"type":57},"2028-06",{"name":5,"class":6},1]