[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532742":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":45,"collaborators":49,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"non-interrupted group","ACTIVE_COMPARATOR","Anticoagulation is continued regardless of atrial fibrillation recurrence.",[13],"Drug: Rivaroxaban",{"label":15,"type":16,"description":17,"interventionNames":18},"PIP anticoagulation group","EXPERIMENTAL","Anticoagulation continuation will be determined based on the rhythm monitored by ILR. If atrial fibrillation persists more than 6 hours a day, anticoagulation should be started at that point on and continued for four weeks. Anticoagulation can be prescribed even in case of less-than-6-hour cumulative atrial fibrillation burden if the investigator decides that the anticoagulation is necessary.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Rivaroxaban","Those in the non-interrupted anticoagulation group, anticoagulation is continued regardless of atrial fibrillation recurrence.\n\nThose in the pill-in-the POCKET anticoagulation group will receive direct oral anticoagulation only if they have atrial fibrillation recur over 6 hours.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Eue-Keun Choi, MD, PhD","CONTACT","82-2-2072-0688","choiek17@snu.ac.kr",[33],{"facility":5,"status":34,"city":35,"state":25,"zip":25,"country":36,"countryCode":25,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Seoul","South Korea",{"type":38,"coordinates":39},"Point",[40,41],126.9784,37.566,{"lat":41,"lon":40},[44],{"name":28,"role":29,"phone":25,"phoneExt":25,"email":31},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Eue-Keun Choi","Professor",[50,53],{"name":51,"class":52},"Samjin Pharmaceutical Co., Ltd.","INDUSTRY",{"name":54,"class":52},"Medtronic","100532742","pill-in-the-pocket-oral-anticoagulation-strategy-after-af-catheter-ablation-100532742",false,"NCT06216769","Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation","Comparison Between Continuous Oral Anticoagulation Versus Pill-in-the-POCKET Oral AntiCoagulation Strategy Guided by Continuous Rhythm Monitoring Using Implantable Loop Recorder After Atrial Fibrillation Catheter Ablation","POCKET-OAC","Inclusion Criteria:\n\n1. Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.\n2. Patients with non-gender CHA2DS2-VASc score 1-4.\n3. Patients who are taking direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) and further plan taking them life-long to prevent stroke caused by atrial fibrillation.\n4. Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with a stroke\u002Ftransient ischemic attack history.\n2. Patients with underlying diseases and bleeding findings contraindicated to anticoagulation (e.g., coagulation disorders, bleeding conditions, significant gastrointestinal bleeding within 6 months of enrollment, history of intracranial\u002Fintraocular\u002Fnontraumatic bleeding, thrombolysis within 48 hours of study enrollment).\n3. Patients who are contraindicated to anticoagulants other than those listed above.\n4. Patients who are hemodynamically unstable at the time of study enrollment: cardiogenic shock, treatment-unresponsive ventricular arrhythmia, or congestive heart failure (NYHA class IV) at the time of randomization.\n5. Patients with underlying severe anemia (hemoglobin \\\u003C8 g\u002FdL at baseline) or a transfusion history within four weeks before visit 1.\n6. Patients with underlying severe thrombocytopenia (platelet count \\\u003C50,000\u002Fmm3)\n7. The patient is under dialysis or chronic renal failure (creatinine clearance \\\u003C15ml\u002Fmin)\n8. The patient has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).\n9. The patient has a contraindication to the implantation of an implantable loop recorder (ILR) (such as limited immunocompetence or a wound-healing disorder).\n10. The patient has severe valvular disease (valvular prosthesis, mitral valve repair; rheumatic mitral stenosis is excluded irrespective of the severity of the disease).\n11. The patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.\n12. Hypertrophic cardiomyopathy\n13. The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).\n14. Patients who are taking warfarin or coumadin.\n15. Patients who are taking dual antiplatelet agents.\n16. Pregnancy, breastfeeding, or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. \\*\n\n    \\* Medically acceptable contraceptives include condoms, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.\n17. Known or suspected malignancy with a history of chemotherapy within 1 year.\n18. The patient has previously implanted cardiac implantable electronic devices or ILR.\n19. Patients with a history of left atrial appendage occlusion or left atrial appendage closure.\n20. The patient is participating in another randomized clinical trial and is under follow-up observation.","ALL","19 Years","89 Years",{"count":67,"type":68},400,"ESTIMATED","INTERVENTIONAL",[71],"NA","The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.",[74],"Atrial Fibrillation",[76,77,78,79,80],"atrial fibrillation","direct oral anticoagulant","catheter ablation","implantable loop recorder","continuous cardiac rhythm monitor","2026-04-28",{"date":83,"type":84},"2026-05-04","ACTUAL",{"date":86,"type":84},"2024-02-01",{"date":88,"type":68},"2030-12-31",{"name":5,"class":6},1]