RecruitingNot ApplicableNCT07279870

RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease

RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease: the ITALIA Study


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

1,260 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Conduction System Pacing (CSP) and a procedure called Right Ventricular (RV) Pacing for people with atrioventricular block. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

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

PROCEDUREConduction 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.

PROCEDURERight 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(14)

Azienda Ospedal iera "Card. G. Panico"

Bari, Italy

IRCCS AOUBO Policlinico di Sant'orsola

Bologna, Italy

Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"

Catania, Italy

Azienda Ospedaliero-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

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NCT07279870


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