Comparing Physiological Ventricular Pacing and Managed Ventricular Pacing to Prevent Persistent Atrial Fibrillation in Patients with Prolonged Atrioventricular Interval

What this Trial Is About

Researchers are evaluating the superiority of physiological ventricular pacing compared to managed ventricular pacing for preventing persistent atrial fibrillation in patients who have a prolonged atrioventricular interval and require pacing due to sinus node disease or certain types of second-degree atrioventricular block. This multicenter, prospective, randomized trial uses CE-marked devices already in clinical practice to compare these pacing methods. The study involves two groups one receiving physiological ventricular pacing PhysioVP, which delivers stimulation to the hearts natural conduction system to correct the PR interval and avoid dyssynchrony, and the other receiving managed ventricular pacing DDD-VPA, which uses right ventricular leads and algorithms to minimize ventricular pacing. Both groups receive atrial leads placed in the right atrial appendage. Patients are implanted with dual-chamber pacemakers and monitored over time. Participants will have in-office clinical checks at 1, 12, 24, and 36 months after implantation, with additional home monitoring at 6, 18, and 30 months. Researchers will measure outcomes such as the occurrence of persistent atrial fibrillation and clinical composite outcomes over 36 months. Secondary measures include heart function, remodeling, and safety endpoints. The study continues monitoring for three years to evaluate the pacing methods impact.

Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval