[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642672":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":26,"collaborators":25,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":25,"enrollmentInfo":40,"targetDuration":25,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":25,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":25},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Atrial flutter ablation","ACTIVE_COMPARATOR","Radiofrequency or pulsed field catheter ablation from the tricuspid annulus to the inferior vena cava in the cavo-tricuspid isthmus",[13],"Device: Catheter ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Atrial flutter ablation + prophylactic pulmonary vein isolation","EXPERIMENTAL","After completion of the standard atrial flutter ablation, radiofrequency, cryoballoon or pulsed field ablation of the pulmonary veins",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Catheter ablation","CTI ablation; pulmonary vein isolation (PVI)",[9,15],null,{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jonathan Steinberg","Research Professor- Department of Medicine, Cardiology Heart Research (SMD)","100642672","prophylactic-pulmonary-vein-isolation-during-atrial-flutter-ablation-100642672",false,"NCT07649603","Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation","Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation: The PREVENT-AF Study II","PREVENT-AF II","Inclusion Criteria:\n\n1. Age ≥ 55 years on date of consent\n2. History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year\n3. Left atrial diameter ≥ 4.5 cm within 12 calendar months prior to or on consent date by transthoracic echocardiography\n4. No identifiable AF on any prior ECG within past 1 year\n5. CHA2DS2 -VASc ≥ 2\n\nExclusion Criteria:\n\n1. Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus)\n2. AFL or AF due to reversible cause e.g. hyperthyroid state\n3. Contraindication to systemic anticoagulation\n4. Prior surgical or percutaneous cardiac ablation procedure any time in the past\n5. Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past\n6. LV ejection fraction \\\u003C 35%\n7. Paroxysmal, persistent or longstanding persistent AF\n8. Presence of NYHA Class IV congestive heart failure\n9. Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and\u002For stent angioplasty) within 3 calendar months prior to consent date\n10. Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent\n11. Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair\u002Freplacement procedures\n12. Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date\n13. Any medical condition likely to limit survival to \\\u003C 1 year\n14. Renal failure requiring dialysis at time of consent\n15. Pregnancy\n16. History of non-compliance to medical therapy\n17. Participation in other clinical trials (observational\u002Flead registries are allowed) without approval from the DCC\n18. Inability or unwillingness to provide informed consent\n19. Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult\n20. Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial","ALL","55 Years",{"count":41,"type":42},620,"ESTIMATED","INTERVENTIONAL",[45],"NA","Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in atrial flutter (AFL) patients.\n\nThis is a multicenter single-blind randomized controlled trial, \"Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation\" (PREVENT AF II) to determine if PVI in conjunction with AFL ablation for patients with typical AFL results in a significant reduction in cardiac events and healthcare utilization.",[48],"Atrial Flutter Typical","NOT_YET_RECRUITING","2026-06-09",{"date":52,"type":53},"2026-06-16","ACTUAL",{"date":55,"type":42},"2027-06",{"date":57,"type":42},"2032-05",{"name":5,"class":6}]