[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648528":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":86,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Catheter - tissue contact assessment","EXPERIMENTAL","Assessment of contact between electrodes on the pulsed field ablation (PFA) catheter and left atrial wall will be made based on change of bipolar intracardiac electrograms (iEGM) after first PFA delivery.",[13],"Device: Electrode tissue contact assessment during pulsed field ablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Electrode tissue contact assessment during pulsed field ablation","Pulsed field ablation (PFA) catheter electrode - tissue contact assessment based on analysis of bipolar intracardiac electrocardiograms: a multipolar PFA catheter will be used for pulmonary vein isolation in a manual mode, which means that instead of delivering fully therapeutic four ablative high voltage pulse trains at each location around pulmonary veins, each of those pulse trains will be delivered manually. Changes (voltage, shape,...) in bipolar intracardiac electrocardiograms (iEGM) measured with ablative catheter electrodes will be assessed after each manual pulse train delivery.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Damijan Miklavčič, PhD","University of Ljubljana","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Matevž Jan, MD, PhD","CONTACT","0038615228238","matevz.jan@kclj.si",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Tine Prolič Kalinšek, MD","tine.prolic.kalinsek@kclj.si",[36],{"facility":5,"status":20,"city":37,"state":20,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Ljubljana","1000","Slovenia","SI",{"type":42,"coordinates":43},"Point",[44,45],14.50513,46.05108,{"lat":45,"lon":44},[48,49],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Jernej Štublar, PhD","SUB_INVESTIGATOR",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Matevz Jan","Head of Electrophysiology Laboratory",[57],{"name":58,"class":59},"Medtronic","INDUSTRY","100648528","assessment-of-catheter-tissue-contact-in-pfa-100648528",false,"NCT07721948","Assessment of Catheter Tissue Contact in PFA","Assessment of Electrode-tissue Contact and Pulmonary Vein Isolation Durability After Pulsed Field Ablation With a Circular \"Single Shot\" Catheter in Patients With Paroxysmal Atrial Fibrillation","ASSESS PFA","Inclusion Criteria:\n\n* Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines\n\nExclusion Criteria:\n\n* Contraindication to pulsed field ablation in the left atrium (e.g., presence of a left atrial appendage occlusion device).\n* Contraindication to undergoing the procedure under general anesthesia.\n* Age \\>80 years.\n* Markedly enlarged left atrium (diameter \\>50 mm on echocardiography, LAVI \\>50 mL\u002Fm²).\n* Life expectancy \\\u003C1 year.\n* Acute life-threatening illness.\n* Presence of left atrial thrombus.\n* Secondary atrial fibrillation.\n* Previous left atrial ablation.","ALL","18 Years","80 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia free success rates remain approximately at the level of previous years and the radiofrequency ablation era.\n\nIsolation durability during PFA procedures might be enhanced by:\n\n1. Intraprocedural monitoring contact of catheter electrode to atrial tissue.\n2. Intraprocedural assessment of the transmurality of irreversible electroporation lesion.\n\nThe aim of our study is to use intracardiac electrogram (iEGM) based analysis for assessment of catheter-tissue contact and PFA lesion durability.",[79],"Atrial Fibrillation (AF)",[81,82,83,84,85],"Atrial Fibrillation","Pulsed field ablation","Intracardiac electrogram","Pulse Select","Contact assessment","NOT_YET_RECRUITING","2026-07-18",{"date":89,"type":90},"2026-07-23","ACTUAL",{"date":92,"type":73},"2026-09-01",{"date":94,"type":73},"2028-09-01",{"name":5,"class":6},1]