Clinical Research Directory

Belgo-Luxembourg Leadless PM Registry

This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott. The study is largely based on a standard-of-care protocol, with the exception of an additional 24-hour Holter monitoring assessment in a selected group of patients after one year, as well as a CT scan (at UZ Leuven only) to accurately determine the position of the pacemaker. The aim of this study is to evaluate real-world safety, electrical performance, and clinical outcomes in patients for whom cardiac pacing is indicated and who will receive or have received one of the Aveir™ LP systems: 1. Aveir™ VR LP system, intended exclusively for ventricular pacing 2. Aveir™ AR LP system, intended exclusively for atrial pacing 3. Simultaneous use of the Aveir™ AR LP and VR LP systems for dual-chamber pacing