[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605455":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":27,"locations":38,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Istituto Auxologico Italiano","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Right atrial ablation group",null,[12],"Procedure: Right atrial ablation",{"label":14,"type":10,"description":10,"interventionNames":15},"Bi-atrial ablation group",[16],"Procedure: Bi-atrial ablation",[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Right atrial ablation","Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to right atrial ablation. The patients receive a right atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Bi-atrial ablation","Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to bi-atrial ablation. The patients receive a bi-atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.",[14],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Michele Brignole, Cardiologist","CONTACT","+393204391422","mbrignole@outlook.it",{"name":34,"role":30,"phone":35,"phoneExt":36,"email":37},"Luca Grappiolo","+3902619111","2894","luca.grappiolo@auxologico.it",[39],{"facility":40,"status":10,"city":41,"state":10,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":10},"IRCCS Istituto Auxologico Italiano","Milan","20149","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],9.18951,45.46427,{"lat":49,"lon":48},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100605455","implantable-loop-recorder-and-cardioneuroblation-100605455",false,"NCT07162740","Implantable Loop Recorder and Cardioneuroblation","Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder","ILR-CNA","Inclusion Criteria:\n\n* Age 18 to 60 years\n* Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines\n* History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures.\n* Documentation by means of prolonged ECG monitoring of an asystolic pause \\>6 sec or of an asystolic syncope \\>3 sec and\u002For an asystolic syncope induced during tilt testing (Vasis 2B form).\n\nExclusion Criteria:\n\n* Intrinsic sinus dysfunction or atrioventricular node disease.\n* Constitutional hypotension and orthostatic intolerance syndromes\n* Overt structural heart disease\n* Alternative diagnoses of syncope\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":64,"type":65},50,"ESTIMATED","12 Months","OBSERVATIONAL","The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope. Currently, some centers perform ablation only in the right atrium, others in both atria (biatrial). There are no comparative studies between the two procedures",[70],"Reflex Syncope",[72,73,74,75,76,77],"Syncope","reflex syncope","implantable loop recorder","Vagal ganglia ablation","Cardioneuroablation","Asystole","NOT_YET_RECRUITING","2025-09-08",{"date":81,"type":82},"2025-09-09","ACTUAL",{"date":84,"type":65},"2025-10-01",{"date":86,"type":65},"2027-10-01",{"name":5,"class":6},1]