RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
ITALIA
2 other identifiers
interventional
1,260
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
December 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2031
December 12, 2025
December 1, 2025
5 years
December 1, 2025
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Heart failure
composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions
36 months after the PM implant
Secondary Outcomes (3)
number of HF events
36 months after the PM implant
HF hospitalizations
36 months after the PM implant
HF non-pharmacological interventions
36 months after the PM implant
Study Arms (2)
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.
Conventional System Pacing/Right Ventricular (RV) Pacing
ACTIVE 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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."
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Ospedale di Rovigo Aulss 5 Polesana
Rovigo, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro Biffi, MD
IRCCS AOUBO Policlinico di Sant'Orsola
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
December 12, 2025
Study Start
December 20, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
June 30, 2031
Last Updated
December 12, 2025
Record last verified: 2025-12