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Recruiting Observational

ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing

NCT06324682 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-01-01
Last updated
2024-03-22

Condition(s) studied

Arrhythmias, CardiacAtrioventricular BlockReduced Systolic FunctionAtrial FibrillationBradyarrhythmiaVentricular TachycardiaVentricular DysfunctionVentricular FibrillationVentricular ArrythmiaAtrioventricular Nodal DiseaseAtrioventricular Conduction DefectsAtrioventricular Block CompleteAtrioventricular Block IncompleteAtrioventricular Junctional RhythmBundle-Branch BlockLeft Bundle-Branch BlockHeart Failure, SystolicBlock;AtrioventricularBlock; ArrhythmicBlock; MobitzBlock, HeartBlock, FascicularBlock Branch Bundle LeftHeart Failure,CongestiveHeart Arrhythmia

Investigational drug(s) / intervention(s)

Cardiac pacing - Conventional RV pacingCardiac pacing - Conduction System PacingCardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)Cardiac pacing - Epicardial pacingCardiac pacing - Leadless pacing

Cardiac pacing - Conventional RV pacing: Implantation of devices for cardiac pacing/defibrillation

Cardiac pacing - Conduction System Pacing: Implantation of devices for cardiac pacing/defibrillation

Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD): Implantation of devices for cardiac pacing/defibrillation

Cardiac pacing - Epicardial pacing: Implantation of devices for cardiac pacing/defibrillation

Cardiac pacing - Leadless pacing: Implantation of devices for cardiac pacing/defibrillation

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Indication for cardiac stimulation * Having performed the implantation of a device for cardiac stimulation Exclusion Criteria: * Age \< 18 years; * Pregnancy status;

Primary outcome measure(s)

  • 30 days efficacy — 30 days
    Number of successful implantations, defined as the achievement of the planned pacing modality
  • Rate of hospitalizations for heart failure at 12 months — 12 months
    The investigators considered the worsening of heart failure requiring hospital management
  • All cause death at 12 months — 12 months
    The investigators will monitor patient's all causes death

Trial sites (31)

FacilityCityRegionStatus
Azienda Ospedaliero-Universitaria di Ferrara Ferrara FE Recruiting
Ospedale San Donato Arezzo Italy Recruiting
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna Bologna Italy Recruiting
spedale Maggiore di Bologna Bologna Italy Recruiting
Ospedale Bernardino Ramazzini Carpi Italy Recruiting
Ospedale SS Annunziata Cento Italy Recruiting
Ospedale Bufalini Cesena Italy Recruiting
Ospedale San Giuseppe Empoli Italy Recruiting
Ospedale di Vaio Fidenza Italy Recruiting
Azienda Ospedaliero-Universitaria Careggi Florence Italy Recruiting
Ospedale San Giovanni di Dio Florence Italy Recruiting
Ospedale Santa Maria Annunziata Bagno a Ripoli Florence Italy Recruiting
Azienda Ospedaliero-Universitaria "Ospedali Riuniti" Foggia Italy Recruiting
Ospedale Morgagni-Pierantoni Forlì Italy Recruiting
Ospedale Santa Maria della Misericordia Grosseto Grosseto Italy Recruiting
Ospedale della Versilia Lido di Camaiore Italy Recruiting
Ospedali Riuniti di Livorno Livorno Italy Recruiting
Ospedale San Luca Lucca Italy Recruiting
Nuovo ospedale Apuano Massa Massa Italy Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena Modena Italy Recruiting
Ospedale Sant'Agostino Estense Modena Baggiovara Modena Italy Recruiting
Ospedale Civico, azienda Ospedaliera di Palermo Palermo Italy Recruiting
Policlinico Paolo Giaccone Palermo Italy Recruiting
Azienda Ospedaliero-Universitaria Maggiore Parma Italy Recruiting
Ospedale Guglielmo da Saliceto Piacenza Piacenza Italy Recruiting
Azienda Ospedaliero-Universitaria pisana Cisanello Pisa Italy Recruiting
Fondazione Toscana Gabriele Monasterio Pisa Italy Recruiting
Ospedale Santa Maria delle Croci Ravenna Italy Recruiting
ASMN Reggio Emilia Reggio Emilia Italy Recruiting
Ospedale degli Infermi Rimini Rimini Italy Recruiting
Azienda Ospedaliero-Universitaria Senese Siena Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06324682 on ClinicalTrials.gov ↗ ← All trials in Italy