ClinicalTrials.gg
RecruitingNCT07279870ITALIAUpdated May 27, 2026

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

An interventional study of Conduction System Pacing (CSP) and Right Ventricular (RV) Pacing in Atrioventricular Block, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 14 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Atrioventricular Block
03

In context

Atrioventricular Block

117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.

This study's planned enrollment of 1,260 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT)
  • \< 35%
  • \< 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."
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,260 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • ProcedureConduction 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.

  • ProcedureRight 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

06

What researchers measure

Primary outcomes

  1. Heart failure

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

    Time frame: 36 months after the PM implant

Secondary outcomes

  1. number of HF events

    number of HF events

    Time frame: 36 months after the PM implant

  2. HF hospitalizations

    HF hospitalizations

    Time frame: 36 months after the PM implant

  3. HF non-pharmacological interventions

    HF non-pharmacological interventions

    Time frame: 36 months after the PM implant

07

Study locations

2 of 14 sites recruiting
  • Azienda Ospedal iera "Card. G. Panico"
    Bari, Italy
    Not yet recruiting
    • Pietro Palmisano, MD · Contact
  • IRCCS AOUBO Policlinico di Sant'orsola
    Bologna, 40138, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
    Catania, Italy
    Not yet recruiting
    • Angelo Antonio Di Grazia · Contact
  • Azienda Ospedaliero-Universitaria di Ferrara
    Ferrara, Italy
    Recruiting
    • Matteo Bertini, MD · Contact
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
    Not yet recruiting
    • Matteo Baroni, MD · Contact
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
    Novara, Italy
    Not yet recruiting
    • Gabriele Dell'Era · Contact
  • Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
    Novara, Italy
    Not yet recruiting
    • Marco Scaglione, MD · Contact
  • Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
    Palermo, Italy
    Not yet recruiting
    • Giuseppe Coppola, MD · Contact
  • Azienda Ospedaliero-Universitaria di Parma
    Parma, Italy
    Not yet recruiting
    • Maria Francesca Notarangelo, MD · Contact
  • Azienda Ospedaliera Santa Maria della Misericordia
    Perugia, Italy
    Not yet recruiting
    • Gianluca Zingarini, MD · Contact
  • Policlinico Casilino
    Roma, Italy
    Not yet recruiting
    • Leonardo Calò, MD · Contact
  • Ospedale di Rovigo Aulss 5 Polesana
    Rovigo, Italy
    Not yet recruiting
    • Francesco Zanon, MD · Contact
  • Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico
    Torino, Italy
    Not yet recruiting
    • Davide Castagno, MD · Contact
  • APSS Trento - Ospedale S. Maria del Carmine di Rovereto
    Trento, Italy
    Not yet recruiting
    • Maurizio Del Greco, MD · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2030, 60 months after the start.

Of 44 interventional studies with no phase under Atrioventricular Block, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2025
First posted
Dec 12, 2025
StartActual
Dec 3, 2025
Primary completionEst.
Dec 31, 2030
CompletionEst.
Jun 30, 2031
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07279870
Responsible party
Sponsor
First posted
Dec 12, 2025
Start date
Dec 3, 2025
Primary completion
Dec 31, 2030 (estimated)
Completion
Jun 30, 2031 (estimated)
Last update
May 27, 2026

Study contacts

Mauro Biffi, MD
Contact
mauro.biffi@aosp.bo.it
+390512149034
Susanna Maltoni, PharmD
Contact
susanna.maltoni@aosp.bo.it
+390512141326
Mauro Biffi, MD
principal investigator · IRCCS AOUBO Policlinico di Sant'Orsola

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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