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RecruitingNCT06324682

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

Sponsor

University Hospital of Ferrara

Enrollment

8,400 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Atrial FibrillationVentricular DysfunctionArrhythmias, CardiacVentricular TachycardiaVentricular ArrythmiaHeart Failure, SystolicLeft Bundle-Branch BlockBradyarrhythmiaAtrioventricular BlockReduced Systolic FunctionVentricular FibrillationAtrioventricular Nodal DiseaseAtrioventricular Conduction DefectsAtrioventricular Block CompleteAtrioventricular Block IncompleteAtrioventricular Junctional RhythmBundle-Branch BlockBlock;AtrioventricularBlock; ArrhythmicBlock; MobitzBlock, HeartBlock, FascicularBlock Branch Bundle Left

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a large registry collecting real-world data on different types of pacemaker and cardiac resynchronization therapy (CRT) devices used to treat abnormal heart rhythms or heart failure. Researchers want to understand how various pacing approaches — left bundle branch pacing, biventricular pacing, right ventricular pacing, and conduction system pacing — compare in terms of patient outcomes. **You may be eligible if:** - You have a medical indication (doctor-recommended reason) for a cardiac pacemaker or other device for heart stimulation - You have already had the device implanted **You may NOT be eligible if:** - You are under 18 years old - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardiac pacing - Conventional RV pacing

Implantation of devices for cardiac pacing/defibrillation

DEVICECardiac pacing - Conduction System Pacing

Implantation of devices for cardiac pacing/defibrillation

DEVICECardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)

Implantation of devices for cardiac pacing/defibrillation

DEVICECardiac pacing - Epicardial pacing

Implantation of devices for cardiac pacing/defibrillation

DEVICECardiac pacing - Leadless pacing

Implantation of devices for cardiac pacing/defibrillation

Locations(31)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, FE, Italy

Ospedale San Donato

Arezzo, Italy

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna

Bologna, Italy

spedale Maggiore di Bologna

Bologna, Italy

Ospedale Bernardino Ramazzini

Carpi, Italy

Ospedale SS Annunziata

Cento, Italy

Ospedale Bufalini

Cesena, Italy

Ospedale San Giuseppe

Empoli, Italy

Ospedale di Vaio

Fidenza, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Ospedale San Giovanni di Dio

Florence, Italy

Ospedale Santa Maria Annunziata Bagno a Ripoli

Florence, Italy

Azienda Ospedaliero-Universitaria "Ospedali Riuniti"

Foggia, Italy

Ospedale Morgagni-Pierantoni

Forlì, Italy

Ospedale Santa Maria della Misericordia Grosseto

Grosseto, Italy

Ospedale della Versilia

Lido di Camaiore, Italy

Ospedali Riuniti di Livorno

Livorno, Italy

Ospedale San Luca

Lucca, Italy

Nuovo ospedale Apuano Massa

Massa, Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Italy

Ospedale Sant'Agostino Estense Modena Baggiovara

Modena, Italy

Ospedale Civico, azienda Ospedaliera di Palermo

Palermo, Italy

Policlinico Paolo Giaccone

Palermo, Italy

Azienda Ospedaliero-Universitaria Maggiore

Parma, Italy

Ospedale Guglielmo da Saliceto Piacenza

Piacenza, Italy

Azienda Ospedaliero-Universitaria pisana Cisanello

Pisa, Italy

Fondazione Toscana Gabriele Monasterio

Pisa, Italy

Ospedale Santa Maria delle Croci

Ravenna, Italy

ASMN Reggio Emilia

Reggio Emilia, Italy

Ospedale degli Infermi Rimini

Rimini, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

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NCT06324682

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