Actively Recruiting
Study of Physiologic Cardiac Stimulation Versus Conventional Pacing in Adults With Atrioventricular Block
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-05-27
1260
Participants Needed
14
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether stimulating the hearts 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 patients 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
Research Team
M
Mauro Biffi, MD
S
Susanna Maltoni, PharmD
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