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

NCT ID: NCT07279870

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2031-06-30

Brief 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.

Conditions

Atrioventricular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Conduction System Pacing (CSP)

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Right Ventricular (RV) Pacing

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauro Biffi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS AOUBO Policlinico di Sant'Orsola

Locations

Ospedale di Rovigo Aulss 5 Polesana

Rovigo, , Italy

Azienda Ospedal iera "Card. G. Panico"

Bari, , Italy

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

Catania, , Italy

Azienda Ospedalie ro-Universitaria di Ferrara

Ferrara, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, , Italy

Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia

Novara, , Italy

Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone

Palermo, , Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Azienda Ospedaliera Santa Maria della Misericordia

Perugia, , Italy

Policlinico Casilino

Roma, , Italy

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

Torino, , Italy

APSS Trento - Ospedale S. Maria del Carmine di Rovereto

Trento, , Italy

Countries

Italy

Central Contacts

Mauro Biffi, MD

Role: CONTACT

mauro.biffi@aosp.bo.it

+390512149034

Susanna Maltoni, PharmD

Role: CONTACT

susanna.maltoni@aosp.bo.it

+390512141326

Facility Contacts

Pietro Palmisano, MD

Role: primary

Angelo Antonio Di Grazia

Role: primary

Matteo Bertini, MD

Role: primary

Matteo Baroni, MD

Role: primary

Gabriele Dell'Era

Role: primary

Giuseppe Coppola, MD

Role: primary

Maria Francesca Notarangelo, MD

Role: primary

Gianluca Zingarini, MD

Role: primary

Leonardo Calò, MD

Role: primary

Francesco Zanon, MD

Role: primary

Davide Castagno, MD

Role: primary

Maurizio Del Greco, MD

Role: primary

Other Identifiers

533/2025/Sper/AOUBo

Identifier Type: OTHER

Identifier Source: secondary_id

ITALIA

Identifier Type: -

Identifier Source: org_study_id