[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625568":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":39,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PVI-plus group","EXPERIMENTAL","Patients allocated in the PVI-plus arm will undergo comprehensive ablation consisting of pulmonary vein isolation, roof line, inferior line, mitral ishtmus line, horizontal line in the left atrium, intercaval line, and cavotricuspid line in the right atrium.",[13],"Procedure: PVI-plus",{"label":15,"type":16,"description":17,"interventionNames":18},"PVI-only group","ACTIVE_COMPARATOR","Patients allocated in the PVI-only arm will undergo pulmonary vein isolation without any additional ablation lesions.",[19],"Procedure: PVI-only",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","PVI-plus","Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PVI-only","Patients randomized to the PVI-only arm will undergo only PVI.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Pavel Osmancik","CONTACT","00420-267163029","pavel.osmancik@gmail.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[40,43,45,47],{"name":41,"class":42},"University Hospital Prague (IKEM), Prague, Czech Republic","UNKNOWN",{"name":44,"class":6},"University Hospital Olomouc",{"name":46,"class":42},"Cardiocenter Podlesí, Trinec, Czech Republic",{"name":48,"class":49},"Faculty Hospital Kralovske Vinohrady","OTHER_GOV","100625568","extended-ablation-versus-pulmonary-vein-isolation-to-treat-persistent-atrial-fibrillation-100625568",false,"NCT07424326","Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation","EXTEND-PVI","Inclusion Criteria:\n\n* symptomatic persistent AF\n* ≥1 episode of persistent AF in the last 12 months\n* signed informed consent\n\nExclusion Criteria:\n\n* first-manifested AF, paroxysmal AF, long-standing persistent AF, permanent AF\n* SR on admission without Class I\u002FIII AADs\n* AF of secondary cause (e.g. hyperthyroidism)\n* any previous LA ablation\n* severe valvular disease (mitral valve insufficiency ≥3+, moderate or severe aortic stenosis) or history of valvular surgery or intervention\n* left ventricular ejection fraction ≤40%\n* pulmonary hypertension (estimated systolic pulmonary artery pressure ≥40 mm Hg)\n* symptomatic coronary artery disease\n* pregnancy\n* LA anteroposterior diameter ≥55 mm\n* body mass index ≥40 kg\u002Fm2\n* age ≥80 years\n* chronic kidney disease stage 3b or higher\n* contraindication to anticoagulation\n* general contraindications of catheter ablation\n* life expectancy \\\u003C2 years due to other comorbidities","ALL","18 Years","80 Years",{"count":61,"type":62},450,"ESTIMATED","INTERVENTIONAL",[65],"NA","The aim is to determine the effect of extended ablation (pre-specified linear PF\u002FRF lesion set) in addition to PVI in symptomatic persistent AF patients on AF\u002FAT\u002FAFL recurrence. The study is designed as multicenter, randomized trial. Eligible patients are patients with persistent AF (but not long-standing persistent AF) planned for a first-ever AF ablation procedure. Patients will be randomly assigned 1:1 either to: i) PVI-only, or ii) PVI-plus arms. Patients in both groups will undergo catheter ablation using an ablation system capable of performing PF and RF ablation (Sphere-9, Affera, Medtronic). Patients randomized to the PVI-only arm will undergo only PVI. Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA). The primary endpoint will be freedom from recurrent AF\u002FAT\u002FAFL, assessed as time-to-first recurrence in the period of 12 months after randomization (post 2-month blanking period). Secondary clinical endpoints will be 1) 12-month differences in AF\u002FAT\u002FAFL burden, 2) AF\u002FAFL\u002FAT-related outcomes (hospitalization or emergency visits), 3) Quality of life according to the AFEQT questionnaire score at 12 months, 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.",[68],"Atrial Fibrillation (AF)",[70,71,72,73,74],"persistent atrial fibrillation","catheter ablation","pulmonary vein isolation","pulsed-field ablation","radiofrequency ablation","NOT_YET_RECRUITING","2026-02-14",{"date":78,"type":79},"2026-02-20","ACTUAL",{"date":81,"type":62},"2026-06-01",{"date":83,"type":62},"2029-12-31",{"name":5,"class":6}]