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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrioventricular Block
• Intervention / Treatment: Procedure: Conduction System Pacing (CSP); Procedure: Right Ventricular (RV) Pacing

• Study Type: Interventional
• Enrollment (Estimated): 1260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro Biffi, MD; Phone Number: +390512149034; Email: mauro.biffi@aosp.bo.it
• Study Contact Backup: Name: Susanna Maltoni, PharmD; Phone Number: +390512141326; Email: susanna.maltoni@aosp.bo.it

Study Locations

• Italy
  • Bari, Italy
    • Not yet recruiting
    • Azienda Ospedal iera "Card. G. Panico"
    • Contact: Pietro Palmisano, MD
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS AOUBO Policlinico di Sant'orsola
    • Contact: Mauro Biffi, MD; Phone Number: 9034 +39051214; Email: mauro.biffi@aosp.bo.it
    • Contact: Susanna Maltoni; Phone Number: 3483530890; Email: susanna.maltoni@aosp.bo.it
  • Catania, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
    • Contact: Angelo Antonio Di Grazia
  • Ferrara, Italy
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Ferrara
    • Contact: Matteo Bertini, MD
  • Milan, Italy
    • Not yet recruiting
    • Asst Grande Ospedale Metropolitano Niguarda
    • Contact: Matteo Baroni, MD
  • Novara, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
    • Contact: Gabriele Dell'Era
  • Novara, Italy
    • Not yet recruiting
    • Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
    • Contact: Marco Scaglione, MD
  • Palermo, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
    • Contact: Giuseppe Coppola, MD
  • Parma, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria di Parma
    • Contact: Maria Francesca Notarangelo, MD
  • Perugia, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Santa Maria della Misericordia
    • Contact: Gianluca Zingarini, MD
  • Roma, Italy
    • Not yet recruiting
    • Policlinico Casilino
    • Contact: Leonardo Calò, MD
  • Rovigo, Italy
    • Not yet recruiting
    • Ospedale di Rovigo Aulss 5 Polesana
    • Contact: Francesco Zanon, MD
  • Torino, Italy
    • Not yet recruiting
    • Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico
    • Contact: Davide Castagno, MD
  • Trento, Italy
    • Not yet recruiting
    • APSS Trento - Ospedale S. Maria del Carmine di Rovereto
    • Contact: Maurizio Del Greco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT)
• Ejection Fraction < 35%
• Life expectancy < 2 years
• Participation in another clinical trial which might impact on the study outcome
• Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.
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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure	composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions	36 months after the PM implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of HF events	number of HF events	36 months after the PM implant
HF hospitalizations	HF hospitalizations	36 months after the PM implant
HF non-pharmacological interventions	HF non-pharmacological interventions	36 months after the PM implant

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Mauro Biffi, MD, IRCCS AOUBO Policlinico di Sant'orsola

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Pathological Conditions, Signs and Symptoms; Atrioventricular Block
• Other Study ID Numbers: ITALIA; 533/2025/Sper/AOUBo (Other Identifier: Comitato Etico AVEC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No