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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Atrioventricular Block

Treatments: Procedure: Conduction System Pacing (CSP); Procedure: Right Ventricular (RV) Pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT07279870

ITALIA

533/2025/Sper/AOUBo (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,260 participants in 2 patient groups

Conduction System Pacing (CSP)

Experimental group

Description:

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.

Treatment:

Procedure: Conduction System Pacing (CSP)

Conventional System Pacing/Right Ventricular (RV) Pacing

Active Comparator group

Description:

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

Treatment:

Procedure: Right Ventricular (RV) Pacing