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Atrioventricular BlockITALIANCT07279870

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

A study testing Conduction System Pacing (CSP) and Right Ventricular (RV) Pacing in people with Atrioventricular Block, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 14 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrioventricular Block
What is being tested?
Conduction System Pacing (CSP) and Right Ventricular (RV) Pacing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
14 sitesItaly
Study dates
3 Dec 2025to 30 Jun 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mauro Biffi, MD contact

+390512149034

mauro.biffi@aosp.bo.it

Susanna Maltoni, PharmD contact

+390512141326

susanna.maltoni@aosp.bo.it

14 sites in 1 country

Italy14 sites, 14 recruiting

  • Azienda Ospedal iera "Card. G. Panico"

    Bari

    Pietro Palmisano, MD

    Not yet recruiting

  • IRCCS AOUBO Policlinico di Sant'orsola

    Bologna, 40138

    Mauro Biffi, MD, +39051214 ext. 9034, mauro.biffi@aosp.bo.it

    Susanna Maltoni, 3483530890, susanna.maltoni@aosp.bo.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"

    Catania

    Angelo Antonio Di Grazia

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara

    Matteo Bertini, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Matteo Baroni, MD

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara

    Gabriele Dell'Era

    Not yet recruiting

  • Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia

    Novara

    Marco Scaglione, MD

    Not yet recruiting

  • Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone

    Palermo

    Giuseppe Coppola, MD

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma

    Maria Francesca Notarangelo, MD

    Not yet recruiting

  • Azienda Ospedaliera Santa Maria della Misericordia

    Perugia

    Gianluca Zingarini, MD

    Not yet recruiting

  • Policlinico Casilino

    Roma

    Leonardo Calò, MD

    Not yet recruiting

  • Ospedale di Rovigo Aulss 5 Polesana

    Rovigo

    Francesco Zanon, MD

    Not yet recruiting

  • Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico

    Torino

    Davide Castagno, MD

    Not yet recruiting

  • APSS Trento - Ospedale S. Maria del Carmine di Rovereto

    Trento

    Maurizio Del Greco, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: 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.

Being tested
Conduction System Pacing (CSP), Right Ventricular (RV) Pacing
Medical subject headings
Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conduction System Pacing (CSP)Procedure or surgery

    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) PacingProcedure or surgery

    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

Study groups in NCT07279870
Study groupRoleWhat they receive
Conduction System Pacing (CSP)ExperimentalCSP 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.
Receives: Procedure: Conduction System Pacing (CSP)
Conventional System Pacing/Right Ventricular (RV) PacingActive comparatorRV 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
Receives: Procedure: Right Ventricular (RV) Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure

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

    Measured: 36 months after the PM implant

Secondary outcomes (3)

  1. number of HF events

    number of HF events

    Measured: 36 months after the PM implant

  2. HF hospitalizations

    HF hospitalizations

    Measured: 36 months after the PM implant

  3. HF non-pharmacological interventions

    HF non-pharmacological interventions

    Measured: 36 months after the PM implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start3 Dec 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279870
Sponsor's protocol ID
ITALIA
Other IDs
533/2025/Sper/AOUBo
Acronym
ITALIA
Status last verified
May 2026
First submitted
1 Dec 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Conduction System Pacing (CSP) and Right Ventricular (RV) Pacing in people with Atrioventricular Block, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mauro Biffi, MD (+390512149034, mauro.biffi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure (time frame: 36 months after the PM implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07279870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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