[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541040":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":62,"centralContacts":67,"locations":72,"responsibleParty":403,"collaborators":10,"id":406,"slug":407,"hasResults":408,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":408,"sex":414,"minAge":415,"maxAge":10,"enrollmentInfo":416,"targetDuration":10,"studyType":419,"phases":10,"briefSummary":420,"conditions":421,"keywords":447,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional right ventricular (RV) pacing",null,"The device (pace maker or implantable cardiac defibrillator) is implanted in the subcutaneous subclavian area (right or left) and it is connected to transvenous lead\u002Fleads (active or passive) implanted in the right cardiac chambers (atrium and ventricle or ventricle only), which detect intrinsic electrical activity and stimulate when needed. The ventricle pacing might be obtained with an apical or septal stimulation.\n\nVascular access might be from the cephalic, axillary or subclavian veins. Once positioned, lead's pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter(s) is(are) fixed and left in place.",[13],"Device: Cardiac pacing - Conventional RV pacing",{"label":15,"type":10,"description":16,"interventionNames":17},"Conduction System Pacing","The approach for the insertion of the device and of the transvenous leads is similar to the previous ones.\n\nThe ventricle activation might be obtained with the his bundle stimulation or with the left bundle branch area pacing downstream of the conduction block. Vascular access might be from the cephalic, axillary or subclavian veins.\n\nBoth selective and non-selective stimulation of the His bundle and the stimulation of the left bundle branch and left septum are considered successful. In both cases, attempts are made to locate the atrio-ventricular junction by fluoroscopic methods or with three-dimensional electroanatomical mapping system. The Hisian potential is sought and the catheter is positioned. In the LBBAP the investigators place the lead 1.5 cm below the His region and, with the pacemaking method, the investigators identify an area that electrocardiographically shows a W signal in V1 lead with D2 more positive than D3 - after checking the electrical parameters.",[18],"Device: Cardiac pacing - Conduction System Pacing",{"label":20,"type":10,"description":21,"interventionNames":22},"Cardiac resynchronization therapy (CRT) either -pacing (CRTP) or -defibrillation (CRTD)","The approach for the insertion of the device and of the transvenous leads is similar to the previous ones.\n\nThe right ventricle pacing (with a pacing lead or a defibrillation coil) might be obtained with an apical or septal stimulation, while the left ventricular pacing is achieved by placing a catheter (active or passive) in the posterolateral area through a venous branch of the coronary sinus.\n\nCardiac resynchronisation therapy (CRT) delivers biventricular or left ventricular only pacing.\n\nVascular access might be from the cephalic, axillary or subclavian veins. Once positioned, lead's pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter(s) is(are) fixed and left in place - paying attention to the phrenic nerve capture threshold.",[23],"Device: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)",{"label":25,"type":10,"description":26,"interventionNames":27},"Epicardial pacing","The device is usually placed in the subcutaneous abdominal area and the lead(s) is(are) secured in the epicardial surface. It is often used in congenital heart defects or post-cardiac surgery scenarios.\n\nSurgeons may access the epicardium during open-heart surgery or with minimally invasive techniques.",[28],"Device: Cardiac pacing - Epicardial pacing",{"label":30,"type":10,"description":31,"interventionNames":32},"Leadless pacing","The leadless device is placed via a percutaneous approach through a large-calibre (femoral) vein inside the right ventricle. It is suitable for patients needing a single chamber pacing such as patients with permanent atrial fibrillation with slow ventricular response, in some cases of paroxysmal atrioventricular block, or patients with a history of CIED infections.\n\nThe only one currently available has a cardiac muscle fixation system consisting of 4 self-expanding barbs.\n\nOnce positioned, pacing threshold, sensing and impedance are measured. If the investigators find good and stable electrical parameters, the catheter is left in place.",[33],"Device: Cardiac pacing - Leadless pacing",[35,42,47,52,57],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Cardiac pacing - Conventional RV pacing","Implantation of devices for cardiac pacing\u002Fdefibrillation",[9],[41],"Cardiac defibrillation - Conventional RV pacing",{"type":36,"name":43,"description":38,"armGroupLabels":44,"otherNames":45},"Cardiac pacing - Conduction System Pacing",[15],[46],"Cardiac defibrillation - Conduction System Pacing",{"type":36,"name":48,"description":38,"armGroupLabels":49,"otherNames":50},"Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)",[20],[51],"Cardiac defibrillation - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)",{"type":36,"name":53,"description":38,"armGroupLabels":54,"otherNames":55},"Cardiac pacing - Epicardial pacing",[25],[56],"Cardiac defibrillation - Epicardial pacing",{"type":36,"name":58,"description":38,"armGroupLabels":59,"otherNames":60},"Cardiac pacing - Leadless pacing",[30],[61],"Cardiac defibrillation - Leadless pacing",[63],{"name":64,"affiliation":65,"role":66},"Matteo Bertini, MD, PhD","Azienda Ospedaliero Universitaria di Ferrara","PRINCIPAL_INVESTIGATOR",[68],{"name":64,"role":69,"phone":70,"phoneExt":10,"email":71},"CONTACT","+390532236269","brtmtt2@unife.it",[73,89,100,112,120,131,142,153,164,175,186,194,202,213,224,235,246,257,268,279,290,298,309,317,328,340,351,359,370,381,392],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Azienda Ospedaliero-Universitaria di Ferrara","RECRUITING","Ferrara","FE","44124","Italy","IT",{"type":82,"coordinates":83},"Point",[84,85],11.62057,44.83804,{"lat":85,"lon":84},[88],{"name":64,"role":69,"phone":70,"phoneExt":10,"email":71},{"facility":90,"status":75,"city":91,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ospedale San Donato","Arezzo",{"type":82,"coordinates":93},[94,95],11.88068,43.46276,{"lat":95,"lon":94},[98],{"name":99,"role":69,"phone":10,"phoneExt":10,"email":10},"Pasquale Notarstefano, MD",{"facility":101,"status":75,"city":102,"state":10,"zip":103,"country":79,"countryCode":80,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna","Bologna","40138",{"type":82,"coordinates":105},[106,107],11.33875,44.49381,{"lat":107,"lon":106},[110],{"name":111,"role":69,"phone":10,"phoneExt":10,"email":10},"Mauro Biffi, MD",{"facility":113,"status":75,"city":102,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"spedale Maggiore di Bologna",{"type":82,"coordinates":115},[106,107],{"lat":107,"lon":106},[118],{"name":119,"role":69,"phone":10,"phoneExt":10,"email":10},"Valeria Carinci, MD",{"facility":121,"status":75,"city":122,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Ospedale Bernardino Ramazzini","Carpi",{"type":82,"coordinates":124},[125,126],10.8777,44.78237,{"lat":126,"lon":125},[129],{"name":130,"role":69,"phone":10,"phoneExt":10,"email":10},"Elia De Maria, MD",{"facility":132,"status":75,"city":133,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Ospedale SS Annunziata","Cento",{"type":82,"coordinates":135},[136,137],11.28716,44.73099,{"lat":137,"lon":136},[140],{"name":141,"role":69,"phone":10,"phoneExt":10,"email":10},"Biagio Sassone, MD",{"facility":143,"status":75,"city":144,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Ospedale Bufalini","Cesena",{"type":82,"coordinates":146},[147,148],12.24315,44.1391,{"lat":148,"lon":147},[151],{"name":152,"role":69,"phone":10,"phoneExt":10,"email":10},"Paolo Sabbatani, MD",{"facility":154,"status":75,"city":155,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Ospedale San Giuseppe","Empoli",{"type":82,"coordinates":157},[158,159],10.94758,43.71795,{"lat":159,"lon":158},[162],{"name":163,"role":69,"phone":10,"phoneExt":10,"email":10},"Attilio Del Rosso, MD",{"facility":165,"status":75,"city":166,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Ospedale di Vaio","Fidenza",{"type":82,"coordinates":168},[169,170],10.06039,44.86694,{"lat":170,"lon":169},[173],{"name":174,"role":69,"phone":10,"phoneExt":10,"email":10},"Paolo Pastori",{"facility":176,"status":75,"city":177,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Azienda Ospedaliero-Universitaria Careggi","Florence",{"type":82,"coordinates":179},[180,181],11.24626,43.77925,{"lat":181,"lon":180},[184],{"name":185,"role":69,"phone":10,"phoneExt":10,"email":10},"Giuseppe Ricciardi, MD",{"facility":187,"status":75,"city":177,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":188,"geoPoint":190,"contacts":191},"Ospedale San Giovanni di Dio",{"type":82,"coordinates":189},[180,181],{"lat":181,"lon":180},[192],{"name":193,"role":69,"phone":10,"phoneExt":10,"email":10},"Iacopo Bertolozzi, MD",{"facility":195,"status":75,"city":177,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Ospedale Santa Maria Annunziata Bagno a Ripoli",{"type":82,"coordinates":197},[180,181],{"lat":181,"lon":180},[200],{"name":201,"role":69,"phone":10,"phoneExt":10,"email":10},"Maria Giaccardi, MD",{"facility":203,"status":75,"city":204,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Azienda Ospedaliero-Universitaria \"Ospedali Riuniti\"","Foggia",{"type":82,"coordinates":206},[207,208],15.55188,41.45845,{"lat":208,"lon":207},[211],{"name":212,"role":69,"phone":10,"phoneExt":10,"email":10},"Pier Luigi Pellegrino, MD",{"facility":214,"status":75,"city":215,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Ospedale Morgagni-Pierantoni","Forlì",{"type":82,"coordinates":217},[218,219],12.04144,44.22177,{"lat":219,"lon":218},[222],{"name":223,"role":69,"phone":10,"phoneExt":10,"email":10},"Alberto Bandini, MD",{"facility":225,"status":75,"city":226,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Ospedale Santa Maria della Misericordia Grosseto","Grosseto",{"type":82,"coordinates":228},[229,230],11.10941,42.76296,{"lat":230,"lon":229},[233],{"name":234,"role":69,"phone":10,"phoneExt":10,"email":10},"Gennaro Miracapillo, MD",{"facility":236,"status":75,"city":237,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Ospedale della Versilia","Lido di Camaiore",{"type":82,"coordinates":239},[240,241],10.2269,43.90012,{"lat":241,"lon":240},[244],{"name":245,"role":69,"phone":10,"phoneExt":10,"email":10},"Gianluca Solarino, MD",{"facility":247,"status":75,"city":248,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Ospedali Riuniti di Livorno","Livorno",{"type":82,"coordinates":250},[251,252],10.32615,43.54427,{"lat":252,"lon":251},[255],{"name":256,"role":69,"phone":10,"phoneExt":10,"email":10},"Federica Lapira, MD",{"facility":258,"status":75,"city":259,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Ospedale San Luca","Lucca",{"type":82,"coordinates":261},[262,263],10.50447,43.84369,{"lat":263,"lon":262},[266],{"name":267,"role":69,"phone":10,"phoneExt":10,"email":10},"Davide Giorgi, MD",{"facility":269,"status":75,"city":270,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Nuovo ospedale Apuano Massa","Massa",{"type":82,"coordinates":272},[273,274],10.13927,44.03541,{"lat":274,"lon":273},[277],{"name":278,"role":69,"phone":10,"phoneExt":10,"email":10},"Giuseppe Arena, MD",{"facility":280,"status":75,"city":281,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Azienda Ospedaliero-Universitaria Policlinico di Modena","Modena",{"type":82,"coordinates":283},[284,285],10.92539,44.64783,{"lat":285,"lon":284},[288],{"name":289,"role":69,"phone":10,"phoneExt":10,"email":10},"Giuseppe Boriani, PhD",{"facility":291,"status":75,"city":281,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"Ospedale Sant'Agostino Estense Modena Baggiovara",{"type":82,"coordinates":293},[284,285],{"lat":285,"lon":284},[296],{"name":297,"role":69,"phone":10,"phoneExt":10,"email":10},"Mauro Zennaro, MD",{"facility":299,"status":75,"city":300,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Ospedale Civico, azienda Ospedaliera di Palermo","Palermo",{"type":82,"coordinates":302},[303,304],13.3636,38.1166,{"lat":304,"lon":303},[307],{"name":308,"role":69,"phone":10,"phoneExt":10,"email":10},"Giuseppe Sgarito, MD",{"facility":310,"status":75,"city":300,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":311,"geoPoint":313,"contacts":314},"Policlinico Paolo Giaccone",{"type":82,"coordinates":312},[303,304],{"lat":304,"lon":303},[315],{"name":316,"role":69,"phone":10,"phoneExt":10,"email":10},"Giuseppe Coppola, MD",{"facility":318,"status":75,"city":319,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Azienda Ospedaliero-Universitaria Maggiore","Parma",{"type":82,"coordinates":321},[322,323],10.32618,44.79935,{"lat":323,"lon":322},[326],{"name":327,"role":69,"phone":10,"phoneExt":10,"email":10},"Francesca Maria Notarangelo, MD",{"facility":329,"status":75,"city":330,"state":10,"zip":331,"country":79,"countryCode":80,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Ospedale Guglielmo da Saliceto Piacenza","Piacenza","29100",{"type":82,"coordinates":333},[334,335],9.69342,45.05242,{"lat":335,"lon":334},[338],{"name":339,"role":69,"phone":10,"phoneExt":10,"email":10},"Luca Rossi, MD",{"facility":341,"status":75,"city":342,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Azienda Ospedaliero-Universitaria pisana Cisanello","Pisa",{"type":82,"coordinates":344},[345,346],10.4036,43.70853,{"lat":346,"lon":345},[349],{"name":350,"role":69,"phone":10,"phoneExt":10,"email":10},"Giulio Zucchelli",{"facility":352,"status":75,"city":342,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":353,"geoPoint":355,"contacts":356},"Fondazione Toscana Gabriele Monasterio",{"type":82,"coordinates":354},[345,346],{"lat":346,"lon":345},[357],{"name":358,"role":69,"phone":10,"phoneExt":10,"email":10},"Andrea Rossi, MD",{"facility":360,"status":75,"city":361,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"Ospedale Santa Maria delle Croci","Ravenna",{"type":82,"coordinates":363},[364,365],12.20121,44.41344,{"lat":365,"lon":364},[368],{"name":369,"role":69,"phone":10,"phoneExt":10,"email":10},"Alessandro Dal Monte",{"facility":371,"status":75,"city":372,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":373,"geoPoint":377,"contacts":378},"ASMN Reggio Emilia","Reggio Emilia",{"type":82,"coordinates":374},[375,376],10.63125,44.69825,{"lat":376,"lon":375},[379],{"name":380,"role":69,"phone":10,"phoneExt":10,"email":10},"Fabio Quartieri, MD",{"facility":382,"status":75,"city":383,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"Ospedale degli Infermi Rimini","Rimini",{"type":82,"coordinates":385},[386,387],12.56528,44.05755,{"lat":387,"lon":386},[390],{"name":391,"role":69,"phone":10,"phoneExt":10,"email":10},"Davide Saporito, MD",{"facility":393,"status":75,"city":394,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":395,"geoPoint":399,"contacts":400},"Azienda Ospedaliero-Universitaria Senese","Siena",{"type":82,"coordinates":396},[397,398],11.33064,43.31822,{"lat":398,"lon":397},[401],{"name":402,"role":69,"phone":10,"phoneExt":10,"email":10},"Amato Santoro, MD",{"type":66,"investigatorFullName":404,"investigatorTitle":405,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Matteo Bertini","Professor","100541040","contemporary-cardiac-stimulation-in-clinical-practice-left-biventricular-right-and-conduction-system-pacing-100541040",false,"NCT06324682","ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","TREEBEARD","Inclusion Criteria:\n\n* Indication for cardiac stimulation\n* Having performed the implantation of a device for cardiac stimulation\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Pregnancy status;","ALL","18 Years",{"count":417,"type":418},8400,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.\n\nParticipants \\[patients over 18 years old with an indication to receive a definitive pacemaker\u002Fintracardiac defibrillator implant\\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.",[422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446],"Arrhythmias, Cardiac","Atrioventricular Block","Reduced Systolic Function","Atrial Fibrillation","Bradyarrhythmia","Ventricular Tachycardia","Ventricular Dysfunction","Ventricular Fibrillation","Ventricular Arrythmia","Atrioventricular Nodal Disease","Atrioventricular Conduction Defects","Atrioventricular Block Complete","Atrioventricular Block Incomplete","Atrioventricular Junctional Rhythm","Bundle-Branch Block","Left Bundle-Branch Block","Heart Failure, Systolic","Block;Atrioventricular","Block; Arrhythmic","Block; Mobitz","Block, Heart","Block, Fascicular","Block Branch Bundle Left","Heart Failure，Congestive","Heart Arrhythmia",[448,449,423,426,428,450,15,451,452,453,454,455,456,433,457,430,429,427],"Pace maker (PM)","Implantable cardioverter defibrillator (ICD)","Cardiac Resynchronization therapy","His Pacing","Left bundle branch area pacing (LBBAP)","CRT","CSP","Primary prevention","Secondary prevention","Heart failure","2024-03-19",{"date":460,"type":461},"2024-03-22","ACTUAL",{"date":463,"type":461},"2023-01-01",{"date":465,"type":418},"2034-12-31",{"name":5,"class":6},31]