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NCT Number: NCT07279870

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

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.

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Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedal iera "Card. G. Panico", Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

Conduction System Pacing (CSP)

Procedure

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.

Right Ventricular (RV) Pacing

Procedure

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 outcomes

  1. Heart failure

    Time frame: 36 months after the PM implant

    composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions

Secondary outcomes

  1. number of HF events

    Time frame: 36 months after the PM implant

    number of HF events

  2. HF hospitalizations

    Time frame: 36 months after the PM implant

    HF hospitalizations

  3. HF non-pharmacological interventions

    Time frame: 36 months after the PM implant

    HF non-pharmacological interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Mauro Biffi, MD

CONTACT

[email protected]

+390512149034

Susanna Maltoni, PharmD

CONTACT

[email protected]

+390512141326

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: ITALIA

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Dec 12, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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