[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583638":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":11,"studyPopulation":19,"armGroups":20,"interventions":11,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":36,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":11,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Texas Cardiac Arrhythmia Research Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrence of atrial arrhythmia: any episode of AF\u002FAT longer than 30 sec off-AAD, after the 2-month blanking period",null,"1 year",[14],{"measure":15,"description":11,"timeFrame":12},"• Arrhythmia-free on previously ineffective AAD without any dose-escalation",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":17,"timePerspective":18,"maskingInfo":11},"CASE_CONTROL","PROSPECTIVE","Persistent atrial fibrillation",[21,24],{"label":22,"type":11,"description":23,"interventionNames":11},"Persistent AF patients receiving PVI (PFA)+ VoM alcohol ablation","PVI:\n\nGeneral periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \\>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below:\n\nFor each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added\n\nPWI:\n\nConcentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion.\n\nVoM:\n\nVoM alcohol ablation procedure will be conducted before the catheter ablation. VoM will be visualized by coronary sinus venography, cannulated with an angioplasty wire and balloon and 1 cc of 98% ethanol will",{"label":25,"type":11,"description":26,"interventionNames":11},"PFA-based PVI+ left atrial posterior wall isolation","PVI:\n\nGeneral periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \\>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below:\n\nFor each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added\n\nPWI:\n\nConcentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion.",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Andrea Natale, MD","CONTACT","5125448186","dr.natale@gmail.com",{"name":34,"role":30,"phone":35,"phoneExt":11,"email":11},"Mitra Mohanty, MD MS","512-544-8198",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Andrea Natale","Executive Medical Director","100583638","safety-and-efficacy-of-pulmonary-vein-isolation-using-pulsed-field-ablation-pfa-combined-with-either-pfa-based-left-atrial-posterior-wall-isolation-or-vein-of-marshall-ethanol-ablation-in-patients-with-persistent-atrial-fibrillation-100583638",false,"NCT06878924","Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation","SAVIOR","Inclusion Criteria:\n\n* Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure\n* Willing to provide informed consent\n* Age: 18-85 years\n\nExclusion Criteria:\n\n* • Previous PWI or VoM ablation procedure\n\n  * Left ventricular ejection fraction \\\u003C40%\n  * Left atrial thrombus\n  * Myocardial infarction within last 60 days\n  * Cardiac surgery in the last 6 months\n  * Advanced renal failure\n  * Life expectancy \\\u003C1 year\n  * Pregnant women\n  * Unable or unwilling to provide informed consent","ALL","18 Years","85 Years",{"count":51,"type":52},162,"ESTIMATED","OBSERVATIONAL","This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.",[56],"Atrial Fibrillation (AF)",[58],"Persistent AF","NOT_YET_RECRUITING","2025-03-10",{"date":62,"type":63},"2025-03-17","ACTUAL",{"date":65,"type":52},"2025-05",{"date":67,"type":52},"2027-12",{"name":5,"class":6}]