Study of BIOTRONIK Dual-Chamber Pacemakers Using Left Bundle Branch Area Pacing and Closed Loop Stimulation Observing Heart Rhythm and Atrial Fibrillation in Patients with Sinus Node Disease and AV Block

What this Trial Is About

Researchers are evaluating the use of BIOTRONIK dual-chamber pacemakers that combine left bundle branch area pacing LBBAP with Closed Loop Stimulation CLS in patients who have sinus node dysfunction SND and atrioventricular AV conduction disorders. This observational study aims to understand how this combined pacing method works in everyday clinical practice and whether it can help reduce atrial fibrillation detected by the device over 24 months. The goal is to gather real-world evidence to optimize pacemaker programming and improve patient outcomes. Participants receive permanent dual-chamber pacemakers with a ventricular lead placed in the left bundle branch area, activating the CLS rate-responsive algorithm. The study focuses on patients implanted with these devices who have no prior history of atrial fibrillation. The study follows about 150 patients for 24 months after implantation, collecting data on device-detected atrial fibrillation episodes, heart rate patterns, and pacing behavior. This is a prospective observational submodule of the BIOSTREAM.CSP registry without a control group. During the study, researchers monitor device-recorded atrial fibrillation incidence and burden from CLS activation up to 24 months. They also analyze heart rate histograms at one and two years after implantation. Patients are enrolled in the BIOSTREAM.CSP registry and are followed through routine clinical care with data collected on pacing rates and arrhythmia episodes. The study aims to provide insights into the clinical performance of CLS combined with LBBAP to inform decisions on pacemaker programming and reduce atrial arrhythmias.

BIO|STREAM.CSP CLS