[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594581":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"R&D Cardiologie","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm, extra applications","EXPERIMENTAL","Pulmonary vein isolation will be performed with the pentaspline ablation catheter in an olive-shape (2x), basket shape (4x), and flower shape (6x) at each vein",[13],"Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm, standard of care","ACTIVE_COMPARATOR","Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.",[19],"Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation","Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation","Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape",[15],[32],{"name":33,"affiliation":34,"role":35},"Lucas VA Boersma, MD, PhD","St. Antonius Hospital","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+31883200900","L.boersma@antoniusziekenhuis.nl",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Isabelle N Bax, MD","+31883200929","i.bax@antoniusziekenhuis.nl",[46],{"facility":34,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Nieuwegein","3435 CM","Netherlands","NL",{"type":53,"coordinates":54},"Point",[55,56],5.08056,52.02917,{"lat":56,"lon":55},[59,62,63],{"name":42,"role":38,"phone":60,"phoneExt":61,"email":44},"0883200929","+31",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":42,"role":64,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"L.V.A. Boersma","Clinical professor","100594581","deliver-more-applications-for-more-durable-pulmonary-vein-isolation-100594581",false,"NCT07021313","Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation","DOPPIO","Inclusion Criteria:\n\n* Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND\n* Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR\n* Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past\n\nExclusion Criteria:\n\n* Cerebrovascular accident (CVA) in the last 6 months\n* More than moderate valvular disease that would require intervention\n* Cardiac catheter\u002Fsurgical intervention in the last 3 months or scheduled\n* Atrial septal defect (ASD)\u002F patent foramen ovale (PFO) closure in the past\n* Left atrial appendage (LAA) closure in the past\n* Mechanical mitral valve\n* Non-adherence to oral anticoagulation in the 3 weeks prior to ablation\n* Renal disease with known eGFR\\\u003C45 ml\n* Left atrial volume index (LAVI) \\>50 ml\u002Fm2 or left atrial diameter (LAD) \\>50 mm\n* Known contra-indication for catheter ablation\n* Known contra-indication for deep sedation or general anesthesia\n* Known pregnancy","ALL","18 Years","80 Years",{"count":79,"type":80},378,"ESTIMATED","INTERVENTIONAL",[83],"NA","Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.",[86],"Atrial Fibrillation",[88,86],"Pulsed Field Ablation","2026-06-25",{"date":91,"type":92},"2026-06-30","ACTUAL",{"date":94,"type":92},"2025-06-20",{"date":96,"type":80},"2028-06",{"name":5,"class":6},1]