protocolSection identificationModule nctId: NCT06324682, orgStudyIdInfo id: 825/2022/Oss/AOUFe, briefTitle: ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing, acronym: TREEBEARD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: 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.Participants \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] 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., conditionsModule conditions: Arrhythmias, Cardiac, conditions: Atrioventricular Block, conditions: Reduced Systolic Function, conditions: Atrial Fibrillation, conditions: Bradyarrhythmia, conditions: Ventricular Tachycardia, conditions: Ventricular Dysfunction, conditions: Ventricular Fibrillation, conditions: Ventricular Arrythmia, conditions: Atrioventricular Nodal Disease, conditions: Atrioventricular Conduction Defects, conditions: Atrioventricular Block Complete, conditions: Atrioventricular Block Incomplete, conditions: Atrioventricular Junctional Rhythm, conditions: Bundle-Branch Block, conditions: Left Bundle-Branch Block, conditions: Heart Failure, Systolic, conditions: Block;Atrioventricular, conditions: Block; Arrhythmic, conditions: Block; Mobitz, conditions: Block, Heart, conditions: Block, Fascicular, conditions: Block Branch Bundle Left, conditions: Heart Failure，Congestive, conditions: Heart Arrhythmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8400, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac pacing - Conventional RV pacing, interventions name: Cardiac pacing - Conduction System Pacing, interventions name: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD), interventions name: Cardiac pacing - Epicardial pacing, interventions name: Cardiac pacing - Leadless pacing, outcomesModule primaryOutcomes measure: 30 days efficacy, primaryOutcomes measure: Rate of hospitalizations for heart failure at 12 months, primaryOutcomes measure: All cause death at 12 months, secondaryOutcomes measure: All cause and cardiovascular death at 1, 3, 5, 10 years, secondaryOutcomes measure: Onset/worsening of heart failure, secondaryOutcomes measure: Onset/worsening of atrial tachyarrhythmias, secondaryOutcomes measure: Onset/worsening of ventricular tachyarrhythmias, secondaryOutcomes measure: Procedural time, secondaryOutcomes measure: Fluoroscopy time, secondaryOutcomes measure: Radiation exposure, secondaryOutcomes measure: Success rate of CRT in heart failure, secondaryOutcomes measure: Cardiac perforation rate, secondaryOutcomes measure: Hemothorax rate, secondaryOutcomes measure: Pneumothorax rate, secondaryOutcomes measure: Pocket hematoma rate, secondaryOutcomes measure: Pericardial effusion rate, secondaryOutcomes measure: Lead dislocation rate, secondaryOutcomes measure: Lead fracture rate, secondaryOutcomes measure: Cardiac Implantable Electronic Devices infections rate, secondaryOutcomes measure: Reintervention rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria di Ferrara, status: RECRUITING, city: Ferrara, state: FE, zip: 44124, country: Italy, contacts name: Matteo Bertini, MD, PhD, role: CONTACT, phone: +390532236269, email: brtmtt2@unife.it, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Ospedale San Donato, status: RECRUITING, city: Arezzo, country: Italy, contacts name: Pasquale Notarstefano, MD, role: CONTACT, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna, status: RECRUITING, city: Bologna, zip: 40138, country: Italy, contacts name: Mauro Biffi, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: spedale Maggiore di Bologna, status: RECRUITING, city: Bologna, country: Italy, contacts name: Valeria Carinci, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Bernardino Ramazzini, status: RECRUITING, city: Carpi, country: Italy, contacts name: Elia De Maria, MD, role: CONTACT, geoPoint lat: 44.78237, lon: 10.8777, locations facility: Ospedale SS Annunziata, status: RECRUITING, city: Cento, country: Italy, contacts name: Biagio Sassone, MD, role: CONTACT, geoPoint lat: 44.73099, lon: 11.28716, locations facility: Ospedale Bufalini, status: RECRUITING, city: Cesena, country: Italy, contacts name: Paolo Sabbatani, MD, role: CONTACT, geoPoint lat: 44.1391, lon: 12.24315, locations facility: Ospedale San Giuseppe, status: RECRUITING, city: Empoli, country: Italy, contacts name: Attilio Del Rosso, MD, role: CONTACT, geoPoint lat: 43.71795, lon: 10.94758, locations facility: Ospedale di Vaio, status: RECRUITING, city: Fidenza, country: Italy, contacts name: Paolo Pastori, role: CONTACT, geoPoint lat: 44.86694, lon: 10.06039, locations facility: Azienda Ospedaliero-Universitaria Careggi, status: RECRUITING, city: Firenze, country: Italy, contacts name: Giuseppe Ricciardi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale San Giovanni di Dio, status: RECRUITING, city: Firenze, country: Italy, contacts name: Iacopo Bertolozzi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Santa Maria Annunziata Bagno a Ripoli, status: RECRUITING, city: Firenze, country: Italy, contacts name: Maria Giaccardi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti", status: RECRUITING, city: Foggia, country: Italy, contacts name: Pier Luigi Pellegrino, MD, role: CONTACT, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Ospedale Morgagni-Pierantoni, status: RECRUITING, city: Forlì, country: Italy, contacts name: Alberto Bandini, MD, role: CONTACT, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Ospedale Santa Maria della Misericordia Grosseto, status: RECRUITING, city: Grosseto, country: Italy, contacts name: Gennaro Miracapillo, MD, role: CONTACT, geoPoint lat: 42.76296, lon: 11.10941, locations facility: Ospedale della Versilia, status: RECRUITING, city: Lido Di Camaiore, country: Italy, contacts name: Gianluca Solarino, MD, role: CONTACT, geoPoint lat: 43.90012, lon: 10.2269, locations facility: Ospedali Riuniti di Livorno, status: RECRUITING, city: Livorno, country: Italy, contacts name: Federica Lapira, MD, role: CONTACT, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Ospedale San Luca, status: RECRUITING, city: Lucca, country: Italy, contacts name: Davide Giorgi, MD, role: CONTACT, geoPoint lat: 43.84369, lon: 10.50447, locations facility: Nuovo ospedale Apuano Massa, status: RECRUITING, city: Massa, country: Italy, contacts name: Giuseppe Arena, MD, role: CONTACT, geoPoint lat: 44.03541, lon: 10.13927, locations facility: Azienda Ospedaliero-Universitaria Policlinico di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Giuseppe Boriani, PhD, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Sant'Agostino Estense Modena Baggiovara, status: RECRUITING, city: Modena, country: Italy, contacts name: Mauro Zennaro, MD, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Civico, azienda Ospedaliera di Palermo, status: RECRUITING, city: Palermo, country: Italy, contacts name: Giuseppe Sgarito, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Policlinico Paolo Giaccone, status: RECRUITING, city: Palermo, country: Italy, contacts name: Giuseppe Coppola, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Azienda Ospedaliero-Universitaria Maggiore, status: RECRUITING, city: Parma, country: Italy, contacts name: Francesca Maria Notarangelo, MD, role: CONTACT, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Ospedale Guglielmo da Saliceto Piacenza, status: RECRUITING, city: Piacenza, zip: 29100, country: Italy, contacts name: Luca Rossi, MD, role: CONTACT, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Azienda Ospedaliero-Universitaria pisana Cisanello, status: RECRUITING, city: Pisa, country: Italy, contacts name: Giulio Zucchelli, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Fondazione Toscana Gabriele Monasterio, status: RECRUITING, city: Pisa, country: Italy, contacts name: Andrea Rossi, MD, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale Santa Maria delle Croci, status: RECRUITING, city: Ravenna, country: Italy, contacts name: Alessandro Dal Monte, role: CONTACT, geoPoint lat: 44.41344, lon: 12.20121, locations facility: ASMN Reggio Emilia, status: RECRUITING, city: Reggio Emilia, country: Italy, contacts name: Fabio Quartieri, MD, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale degli Infermi Rimini, status: RECRUITING, city: Rimini, country: Italy, contacts name: Davide Saporito, MD, role: CONTACT, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Azienda Ospedaliero-Universitaria Senese, status: RECRUITING, city: Siena, country: Italy, contacts name: Amato Santoro, MD, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, hasResults: False