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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation

• male and female

• acquired informed consent

Locations
Other Locations
Italy
Azienda Ospedal iera Card. G. Panico
NOT_YET_RECRUITING
Bari
IRCCS AOUBO Policlinico di Sant'orsola
RECRUITING
Bologna
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico -San Marco
NOT_YET_RECRUITING
Catania
Azienda Ospedaliero-Universitaria di Ferrara
RECRUITING
Ferrara
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
NOT_YET_RECRUITING
Novara
Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
NOT_YET_RECRUITING
Novara
Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
NOT_YET_RECRUITING
Palermo
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Azienda Ospedaliera Santa Maria della Misericordia
NOT_YET_RECRUITING
Perugia
Policlinico Casilino
NOT_YET_RECRUITING
Roma
Ospedale di Rovigo Aulss 5 Polesana
NOT_YET_RECRUITING
Rovigo
Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico
NOT_YET_RECRUITING
Torino
APSS Trento - Ospedale S. Maria del Carmine di Rovereto
NOT_YET_RECRUITING
Trento
Contact Information
Primary
Mauro Biffi, MD
mauro.biffi@aosp.bo.it
+390512149034
Backup
Susanna Maltoni, PharmD
susanna.maltoni@aosp.bo.it
+390512141326
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 1260
Treatments
Experimental: 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.
Active_comparator: Conventional System Pacing/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
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov