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

Official title

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

Overview

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.

Interventions

• 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.
• 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

Primary outcome measures

• Heart failure [Time frame: 36 months after the PM implant]

Secondary outcome measures (3)

• number of HF events [Time frame: 36 months after the PM implant]
• HF hospitalizations [Time frame: 36 months after the PM implant]
• HF non-pharmacological interventions [Time frame: 36 months after the PM implant]

Eligibility criteria

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."

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Italy · 14 centers

• Azienda Ospedal iera "Card. G. Panico" — Bari
• IRCCS AOUBO Policlinico di Sant'orsola — Bologna
• Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco" — Catania
• Azienda Ospedaliero-Universitaria di Ferrara — Ferrara
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara — Novara
• Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia — Novara
• Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone — Palermo
• … and 6 more centers

Identifiers

NCT: NCT07279870 · ITALIA · 533/2025/Sper/AOUBo

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗