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RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Summary
Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.
Official title: RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease: the ITALIA Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1260
Start Date
2025-12-20
Completion Date
2031-06-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Conduction System Pacing (CSP)
CSP occurs at the left endocardic surface of the interventricular septum hence specifically designed delivery catheters are used to advance the ventricular lead across the septum until its left-sided edge, where the Left Bundle is located. To determine whether CSP has been achieved, a standard 12-lead electrocardiogram (ECG) is continuously recorded.
Right Ventricular (RV) Pacing
RV pacing delivered either at the RV apex or RV septum. RV pacing is delivered by single chamber or dual chamber pacemakers depending on patients' rhythm (sinus or AT/AF) according to well-established clinical practice as described in the EHRA recommendtions
Locations (13)
Azienda Ospedal iera "Card. G. Panico"
Bari, Italy
Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
Catania, Italy
Azienda Ospedalie ro-Universitaria di Ferrara
Ferrara, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
Novara, Italy
Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Azienda Ospedaliera Santa Maria della Misericordia
Perugia, Italy
Policlinico Casilino
Roma, Italy
Ospedale di Rovigo Aulss 5 Polesana
Rovigo, Italy
Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico
Torino, Italy
APSS Trento - Ospedale S. Maria del Carmine di Rovereto
Trento, Italy