Actively Recruiting
Randomised Study of Physiologic Cardiac Stimulation in Patients With Atrioventricular Conduction Disease: the ITALIA Study
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-05-27
1260
Participants Needed
14
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether stimulating the heart's conduction system reduces heart failure events in patients with atrioventricular block and how this approach compares to conventional pacing in real-world clinical practice. The study also aims to assess the impact of these treatments on patients' quality of life and cost-effectiveness. This trial involves adult patients who need a pacemaker due to atrioventricular conduction disease. Participants will be randomly assigned to one of two groups: conduction system pacing (CSP) or conventional right ventricular (RV) pacing. CSP uses specialized catheters to place the pacing lead at the left side of the interventricular septum near the left bundle branch, with continuous ECG monitoring to confirm correct placement. The conventional pacing group receives RV pacing at the apex or septum of the right ventricle using single or dual chamber pacemakers, chosen based on the patient's heart rhythm. During the 36 months following pacemaker implantation, patients will be followed to monitor heart failure outcomes, including heart failure events, hospitalizations, and non-drug interventions. Quality of life and cost-effectiveness will also be evaluated. The study uses randomization and quadruple masking to ensure unbiased assessment, and participants will be monitored regularly to track their health and treatment effects over the study period.
CONDITIONS
Brief Title
RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with AV block in either sinus rhythm or permanent atrial tachycardia/atrial fibrillation, or with slow AV conduction during AT/AF, or undergoing AV node ablation plus ventricular stimulation
- Male and female patients
- Provided informed consent to participate
You will not qualify if you...
- Class I indication for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy
- Ejection fraction less than 35%
- Life expectancy less than 2 years
- Participation in another clinical trial that might affect study results
- Pregnancy, except if doctor and patient jointly agree participation is appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months after pacemaker implant
Participants receive cardiac pacing through either Conduction System Pacing (CSP) or Right Ventricular (RV) Pacing according to their assigned group.
Initial implantation visit followed by regular follow-up visits during treatment
Trial Site Locations
Total: 14 locations
1
Azienda Ospedal iera "Card. G. Panico"
Bari, Italy
Not Yet Recruiting
2
IRCCS AOUBO Policlinico di Sant'orsola
Bologna, Italy, 40138
Actively Recruiting
3
Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
Catania, Italy
Not Yet Recruiting
4
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Actively Recruiting
5
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Not Yet Recruiting
6
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Not Yet Recruiting
7
Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
Novara, Italy
Not Yet Recruiting
8
Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
Palermo, Italy
Not Yet Recruiting
9
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Not Yet Recruiting
10
Azienda Ospedaliera Santa Maria della Misericordia
Perugia, Italy
Not Yet Recruiting
11
Policlinico Casilino
Roma, Italy
Not Yet Recruiting
12
Ospedale di Rovigo Aulss 5 Polesana
Rovigo, Italy
Not Yet Recruiting
13
Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico
Torino, Italy
Not Yet Recruiting
14
APSS Trento - Ospedale S. Maria del Carmine di Rovereto
Trento, Italy
Not Yet Recruiting
Research Team
M
Mauro Biffi, MD
S
Susanna Maltoni, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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