Long-Term Observation of Patients Using BIOTRONIK Devices for Conduction System Pacing Monitoring Outcomes and Safety of the Solia CSP S Lead Implantation

What this Trial Is About

This observational study evaluates the long-term outcomes, performance, and safety of BIOTRONIK devices used for conduction system pacing CSP in real-life clinical settings. It focuses on patients who receive these devices for cardiac pacing, including those with pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter defibrillators, addressing conditions like bradycardia, tachycardia, and heart failure. Participants receive the Solia CSP S pacing lead for left bundle branch area pacing LBBAP as part of their routine care with BIOTRONIK devices. The study includes patients intended for new implantation or those recently implanted with investigational generators and leads positioned deep within the intraventricular septum. The study observes patients over an average of four years, monitoring device-related safety and electrical parameters through annual evaluations. Participants are involved in regular follow-up visits and use the BIOTRONIK Home Monitoring system via CardioMessenger to track device performance. Researchers measure rates of successful implantation, capture types, pacing thresholds, sensing amplitudes, and pacing impedance throughout the study. Safety is assessed by monitoring serious adverse device effects during the study period. The total participation time averages about four years, with annual assessments to support long-term device evaluation.

BIO|STREAM.CSP Study