[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464529":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":61,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Split, School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ERAF after PFA",null,"Patients with an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.",[13],"Other: Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation",{"label":15,"type":10,"description":16,"interventionNames":17},"no ERAF after PFA","Patients without an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation","The implanted loop recorder will be interrogated to see how many patients had an early recurrence of AF (up to 3 months after the procedure). Then the late recurrence rate will be compared (3-12 months post-procedure) between groups with and without early recurrences.",[9,15],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Lucija Lisica, MD","CONTACT","+385995094697","lucijalisica21@gmail.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Zrinka Jurišić, Ass. Prof., MD","+385915262844","zrinkacn@gmail.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Hospital Center Split","RECRUITING","Split","Split-Dalmatia County","21000","Croatia","HR",{"type":43,"coordinates":44},"Point",[45,46],16.43915,43.50891,{"lat":46,"lon":45},[49,50,52,55,57,59],{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},{"name":25,"role":51,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":53,"role":54,"phone":10,"phoneExt":10,"email":10},"Ivan Sikiric, MD","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":10,"phoneExt":10,"email":10},"Ante Anic, MD",{"name":58,"role":54,"phone":10,"phoneExt":10,"email":10},"Toni Breskovic, MD, PhD",{"name":60,"role":54,"phone":10,"phoneExt":10,"email":10},"Zrinka Jurisic, Ass. Prof., MD",{"type":51,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lucija Lisica","Principal Investigator","100464529","early-recurrences-of-atrial-arrhythmias-and-their-impact-on-late-recurrence-after-pulmonary-vein-isolation-with-pulsed-field-ablation-of-paroxysmal-atrial-fibrillation-100464529",false,"NCT05328882","Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation","Inclusion Criteria:\n\n* Age \\>18\n* Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days)\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Any known contraindication to AF ablation or anticoagulation.\n* History of previous left atrial ablation or surgical treatment.\n* Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance.\n* Asymptomatic AF patients, persistent AF, permanent AF patients.\n* History of clotting or bleeding disease or cryoglobulinemia.\n* Pregnant or lactating.\n* Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population.","ALL","18 Years","75 Years",{"count":74,"type":75},40,"ESTIMATED","OBSERVATIONAL","This is a prospective, single-arm study conducted in University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1 month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, 12 months post-procedure. Median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.",[79,80],"Atrial Fibrillation Paroxysmal","Recurrence",[82],"Pulsed field ablation","UNKNOWN","2023-10-04",{"date":86,"type":87},"2023-10-06","ACTUAL",{"date":89,"type":87},"2021-11-17",{"date":91,"type":75},"2024-05-17",{"name":5,"class":6},1]