Long-Term Safety and Benefits of Left Bundle Branch Area Pacing Using the INGEVITY Pacemaker Lead in Adults with Bradycardia

What this Trial Is About

The trial investigates the long-term safety, performance, and clinical benefits of pacing the left bundle branch area using the INGEVITY pacemaker lead in adults with bradycardia who require a pacemaker. This observational post-market clinical follow-up study aims to gather information on how well this pacing method works and its effects over time. Participants will receive an INGEVITY bipolar, steroid-releasing pacemaker lead implanted in the left bundle branch area, connected to a compatible Boston Scientific single- or dual-chamber pacemaker. The implantation is performed using a CE-marked catheter designed for chronic stimulation and sensing. This study focuses on patients receiving this specific Boston Scientific pacemaker system and lead combination. Throughout the study, participants will be monitored for implant success and maintenance of ventricular synchrony, assessed from the implant procedure through a three-year follow-up period. Evaluations include clinical visits and testing as outlined by the protocol. The study measures pacing performance and safety, with participants involved in ongoing assessments to track outcomes over several years.

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up