[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kardium Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,37,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100642212","globe-registry-globe-pulsed-field-system-registry-study-for-treating-patients-with-symptomatic-atrial-fibrillation-100642212",false,"NCT07651852","Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation","Key Inclusion Criteria:\n\n* Patients with a planned ablation procedure using the commercially available Globe PF System\n\nKey Exclusion Criteria:\n\n* Patients whose life expectancy is 1 year or less\n* Contraindication to left atrial catheter ablation or PF ablation\n* Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium","ALL","18 Years",{"count":18,"type":19},500,"ESTIMATED","12 Months","OBSERVATIONAL","This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).",[24],"Atrial Fibrillation","NOT_YET_RECRUITING","2026-06-11",{"date":28,"type":29},"2026-06-16","ACTUAL",{"date":31,"type":19},"2026-07",{"date":33,"type":19},"2029-10",{"name":35,"class":36},"Kardium Inc.","INDUSTRY",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100451869","safety-and-performance-of-a-pulsed-field-device-for-global-mapping-and-ablation-of-the-left-atrium-for-the-treatment-of-atrial-fibrillation-100451869","NCT05164107","Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation","PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation","PULSE-EU","Key Inclusion Criteria:\n\n1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF.\n\n   1. Diagnosis must be confirmed within 12 months before enrollment.\n   2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation\n2. Subjects between 18 and 75 years of age, inclusive\n\nKey Exclusion Criteria:\n\n1. Patients who have contraindications to open heart surgery\n2. Patients from an Intensive Care Unit\n3. Patients with active systemic infection (sepsis)\n4. Patients who have had previous ablation in the left or right atrium\n5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery\n6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)\n7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation\n8. Patients with New York Heart Association Class III or IV heart failure\n9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)\n10. Bleeding disorder history\n11. Patients with a known sensitivity to anesthesia or neuromuscular block agent\n12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease\n13. Myocardial infarction within the last three months\n14. Atrioventricular (AV) block II° or III°\n15. Left ventricular ejection fraction (LVEF) of less than 35%\n16. Unstable angina","75 Years",{"count":47,"type":19},175,"INTERVENTIONAL",[50],"NA","The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).",[24],[54,24,55],"Globe Mapping and Ablation System","Pulsed Field Ablation","RECRUITING","2026-01-28",{"date":59,"type":29},"2026-01-30",{"date":61,"type":29},"2021-12-08",{"date":63,"type":19},"2027-05",{"name":35,"class":36},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":48,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":65},"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","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","80 Years",{"count":75,"type":19},115,[50],"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.",[79,80],"Paroxysmal Atrial Fibrillation (PAF)","Persistent Atrial Fibrillation",[55],"2025-06-13",{"date":84,"type":29},"2025-06-16",{"date":86,"type":29},"2025-06-10",{"date":88,"type":19},"2028-06",{"name":35,"class":36},""]