[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566591":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":26},{"fullName":5,"class":6},"Centro Medico Teknon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PV reconnection + HSC ablation","EXPERIMENTAL","Patients undergoning pulmunary veins (PV) reconnection checking and ablation plus identification and ablation of hidden sites of slow conduction (HSC)",[13],"Procedure: Pulmunary veins reconnection plus hidden slow conduction ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"PV reconnection ablation only","ACTIVE_COMPARATOR","Patients undergoning PV reconnection checking and ablation only.",[19],"Procedure: Pulmunary veins (PV) reconnection ablation only",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Pulmunary veins reconnection plus hidden slow conduction ablation","Ablation of pulmonary veins reconnections plus the search and ablation of hidden slow conductions sites (HSC) in the left atrium.\n\nHSC sites are defined as EGMs showing highly fragmented or double electrograms in response atrial triple extrastimulus, presenting normal or fractionated electrogram in the sinus rhythm.\n\nAfter checking for PV's conduction breakthroughs, point-by point ablation targeting HSC-EGMs will be performed.\n\nThe end point for HSC+ ablation will be reached with loss of local capture at a given lesion, pacing from the ablation catheter at high output (10V·2ms).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pulmunary veins (PV) reconnection ablation only","Each vein will be re-assessed by observing PV potentials along the PV ostia and by pacing from the distal bipole of the ablation catheter (10mA at 2ms) within the lesion set with failed capture of the left atrium. In case of PVs reconnection touch-up applications will be performed at the earliest potential site, identified by comparing far-field atrial EGM to near-field local EGM timing, until isolation will be achieved (entrance and exit block).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Antonio Berruezo Sanchez, MD, PHD","CONTACT","3384090290","antonio.berruezo@quironsalud.es",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Antonio Berruezo, MD, PhD","Director of Electrophysiology unit","100566591","hidden-slow-conduction-ablation-for-recurrent-atrial-fibrillation-unmasking-the-arrhythmogenic-substrate-unmask-af-100566591",false,"NCT06657170","Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate (Unmask-AF)","Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate","Inclusion Criteria:\n\n* Recurrent paroxysmal AF (continuous AF episode lasting longer than 30 s but terminating spontaneously or with intervention within 7 days of onset), recurrent persistent AF (continuous AF episode lasting longer than 7 days but \\\u003C 1 year) and recurrent long standing persistent AF (continuous AF ≥1 year in duration, in patients where rhythm control management is being pursued)\n* Previous PVI procedure\n* Age \\> 40 years\n* Willing and capable of providing consent\n* Able and willing to comply with all follow-up testing and requirements\n\nExclusion Criteria:\n\n* Additional left atrial ablations during the previous procedures (es. posterior wall isolation, anterior line, roof line, CFAE and others)\n* Acute illness, active systemic infection, or sepsis\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.\n* Severe mitral regurgitation\n* Women who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation","ALL","40 Years",{"count":51,"type":52},212,"ESTIMATED","INTERVENTIONAL",[55],"NA","Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. However, there is still a notable lack of randomized evidence in this area, which limits guidance and decision-making in clinical practice. Recently, the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms (EGMs) in AF patients, termed as hidden slow conduction (HSC). Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate, offering a potential target for ablation This multi-center, prospective, randomized, controlled trial will include two arms: one investigational (PV reconnection + HSC) and one control (PV reconnection). All the subjects will be followed for 12 months after the ablation procedure.\n\nThe aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures. The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure.",[58],"Atrial Fibrillation",[60,61,62,63],"Catheter Ablation","Re-do Procedures","Hidden Slow Conduction","Functional Substrate Ablation","NOT_YET_RECRUITING","2024-12-08",{"date":67,"type":68},"2024-12-12","ACTUAL",{"date":70,"type":52},"2024-12",{"date":72,"type":52},"2027-09",{"name":5,"class":6}]