[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547026":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulmonary vein isolation with diagnostic RETRO-Mapping only","PLACEBO_COMPARATOR","All patients will undergo standard pulmonary vein isolation (PVI) procedures with 3D electroanatomic mapping using the CARTO™ system (Biosense Webster, USA), or the EnSite X™ system (Abbott, USA). A decapolar catheter will be inserted into the coronary sinus. A 3D electroanatomic map of the left atrium will be created and all pulmonary veins will be identified. Radio-frequency ablation will be performed to achieve PVI.\n\nAfter the PVI procedure, patients in the control arm will have the same mapping for identification and categorisation of focal sources, but no adjunctive ablation. RETRO-Mapping will be performed using custom-built hardware called Tau20 that has been validated for reproducibility against existing commercial technologies.",[13,14],"Procedure: Pulmonary vein isolation","Diagnostic Test: RETRO-Mapping without adjunctive ablation",{"label":16,"type":17,"description":18,"interventionNames":19},"Pulmonary vein isolation with adjunctive ablation guided by RETRO-Mapping","EXPERIMENTAL","In addition to and after the PVI procedure, patients the intervention arm will then have RETRO-Mapping performed of the remaining atria and atrial fibrillation cycle length measured in coronary sinus and left atrial appendage. Each segment will be mapped for 30 seconds and the activation pattern categories; if focal activation is identified, it will then be ablated. A further 30 seconds will be mapped at the same segments post-ablation to determine effect. The coronary sinus and left atrial appendage cycle length will be documented at the start of RETRO-Mapping and after each lesion set.",[13,20],"Procedure: Adjunctive ablation guided by RETRO-Mapping",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Pulmonary vein isolation","Standard clinical radio-frequency ablation isolation of pulmonary veins",[16,9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DIAGNOSTIC_TEST","RETRO-Mapping without adjunctive ablation","RETRO-Mapping performed using research equipment and software, but without any adjunctive ablation",[9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Adjunctive ablation guided by RETRO-Mapping","Radio-frequency ablation using a European conformity (CE)-marked ablation catheter of sites of focal activation identified by RETRO-Mapping",[16],[38],{"name":39,"affiliation":5,"role":40},"Prapa Kanagaratnam, FRCP PhD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":27,"email":45},"CONTACT","‭020 3312 6666‬","p.kanagaratnam@imperial.ac.uk",{"name":47,"role":43,"phone":27,"phoneExt":27,"email":48},"Oliver S Jones, MRCP","o.jones@imperial.ac.uk",[50],{"facility":51,"status":52,"city":53,"state":27,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Hammersmith Hospital","RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":58,"coordinates":59},"Point",[60,61],-0.12574,51.50853,{"lat":61,"lon":60},[64,66],{"name":65,"role":43,"phone":44,"phoneExt":27,"email":45},"Prapa Kanagaratnam, PhD FRCP",{"name":47,"role":43,"phone":27,"phoneExt":27,"email":48},{"type":68,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[70],{"name":71,"class":6},"Imperial College Healthcare NHS Trust","100547026","ablation-of-focal-activation-in-atrial-fibrillation-100547026",false,"NCT06402617","Ablation of Focal Activation in Atrial Fibrillation","Ablation of Focal Activation During Persistent Atrial Fibrillation to Determine the Characteristics of Focal Drivers","RETRO-AF","Inclusion Criteria:\n\n* Persistent atrial fibrillation with clinical indication for catheter ablation\n* Clinically suitable candidate for catheter ablation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous atrial fibrillation or other catheter ablation procedure\n* Clinical contraindication to catheter ablation or general anaesthetic, including history of adverse reaction to contrast media, or presence of intracardiac thrombus, or inadequate anticoagulation in the preceding 6 weeks\n* Valvular disease graded moderate or greater, or presence of a prosthetic valve\n* Moderate-to-severe heart failure, defined as left ventricular ejection fraction \\\u003C35% and\u002For New York Heart Association class III-IV\n* Any form of cardiomyopathy\n* Active infection or fever\n* Severe cerebrovascular disease\n* Active gastrointestinal bleeding\n* Bleeding or clotting disorders, clinically high bleeding risk, or clinical contraindication to receiving heparin\n* Baseline serum creatinine \\>200umol\u002FL\n* Currently receiving or at risk of requiring renal replacement therapy\n* Uncontrolled diabetes (HbA1c ≥73mmol\u002Fmol or HbA1c ≤64mmol\u002Fmol and fasting blood glucose ≥9.2mmol\u002FL)\n* Malignancy necessitating therapy\n* Life expectancy shorter than the duration of the trial\n* Pregnancy, or childbearing potential and not using a highly effective method of contraception\n* Inability to provide informed consent to participate in the trial","ALL","18 Years","85 Years",{"count":84,"type":85},110,"ESTIMATED","INTERVENTIONAL",[88],"NA","Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF). However, it has not been possible to show similar focal drivers during AF, owing to the limitations of mapping in persistent AF. RETRO-Mapping has been developed as a method to generate activation maps during AF to test the hypothesis that persistent AF is also maintained by focal drivers.\n\nRETRO-Mapping is able to locate sites of focal activation that were isolated, intermittent, or recurrent during persistent AF. However, a 30-second segment of AF can have approximately 150 wavefronts in a small area of myocardium. Screening for focal activation and manually validating these prior to ablation was not feasible using current commercial systems.\n\nRETRO-Mapping can automatically detect focal activation and a recording system that enables the intracardiac signals to be directly analysed by the RETRO-Mapping software. This will allow RETRO-Mapping to build a detailed classification of focal activation types and study the impact of ablation of these sites on the AF cycle length, to address the hypothesis that persistent AF is maintained by focal drivers.",[91,92,93,94,95],"Atrial Fibrillation","Atrial Fibrillation, Persistent","Arrhythmia","Arrhythmias, Cardiac","Cardiac Arrhythmia",[97,98,99,100,101,102],"ablation","electrophysiology","mapping","local activation time","pulmonary vein isolation","atrial fibrillation cycle length","2024-05-02",{"date":105,"type":106},"2024-05-07","ACTUAL",{"date":108,"type":106},"2024-04-30",{"date":110,"type":85},"2026-10",{"name":5,"class":6},1]