[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590589":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":31,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":20,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":57,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":20},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Empiric pulsed field pulmonary vein isolation","EXPERIMENTAL","Patients will receive general endotracheal anesthesia or conscious sedation provided by cardiac anesthesiology and usual vascular access for their clinically indicated catheter ablation for AT. Usual diagnostic methods including programmed electrical stimulation for arrhythmia induction and electroanatomic activation and voltage mapping will be performed followed by RFA (using standard-of-care, commercially-available RFA catheters) of any observed AT. After conclusion of AT ablation, transseptal or transbaffle puncture will be performed under fluoroscopic and intracardiac echocardiography guidance to access the left atrium (LA) or pulmonary venous atrium (PVA) if not already done so. PFA will be performed using a pentaspline catheter (Farawave, Boston Scientific) and a steerable sheath to achieve PVI of all veins draining to the LA\u002FPVA with entrance and exit block confirmed at each vein. In patients where PFA is unable to achieve PVI, touch-up RFA will be performed.",[13],"Device: Pulsed field ablation using a pentaspline ablation catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Pulsed field ablation using a pentaspline ablation catheter","After conclusion of AT ablation, transseptal or transbaffle puncture will be performed under fluoroscopic and intracardiac echocardiography guidance to access the left atrium (LA) or pulmonary venous atrium (PVA) if not already done so. PFA will be performed using a pentaspline catheter (Farawave, Boston Scientific) and a steerable sheath to achieve PVI of all veins draining to the LA\u002FPVA with entrance and exit block confirmed at each vein. In patients where PFA is unable to achieve PVI, touch-up RFA will be performed. Programmed atrial stimulation will be performed to investigate for inducible atrial tachycardias. An implantable loop recorder will be placed at the conclusion of the procedure.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Edward O'Leary, MD","CONTACT","6173557833","toleary87@gmail.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Edward O'Leary","Physician",[32],{"name":33,"class":6},"Brigham and Women's Hospital","100590589","empiric-pulsed-field-pulmonary-vein-isolation-during-atrial-tachycardia-ablation-in-adults-with-congenital-heart-disease-100590589",false,"NCT06969378","Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease","Inclusion Criteria:\n\n* Adult patients (\\>= 18 years of age) with repaired or unrepaired congenital heart disease and a history of sustained (\\>30 seconds) AT\n\nExclusion Criteria:\n\n* History of sustained AF and\u002For previous catheter or surgical pulmonary vein isolation.","ALL","18 Years",{"count":43,"type":44},30,"ESTIMATED","INTERVENTIONAL",[47],"NA","This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease (CHD) who are presenting for atrial tachycardia (AT) ablation.",[50,51,52,53,54,55,56],"Atrial Fibrillation","Atrial Tachycardia","Atrial Flutter","Congenital Heart Disease","Pulmonary Vein Isolation","Pulsed Field Ablation","Catheter Ablation",[58,59,60,61,62,63,64,65],"atrial fibrillation","atrial tachycardia","atrial flutter","pulsed field ablation","congenital heart disease","adult congenital heart disease","pulmonary vein isolation","catheter ablation","NOT_YET_RECRUITING","2025-05-05",{"date":69,"type":70},"2025-05-13","ACTUAL",{"date":72,"type":44},"2025-07-01",{"date":74,"type":44},"2026-06-30",{"name":5,"class":6}]