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

Efficacy and Safety of Micra AV2 Transcatheter Pacing System

A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model. The new algorithms permit the delivery of AV synchronous pacing, improving the automatic AV synchrony at faster heart rates between 80-100 bpm with a maximal upper tracking rate limit of 135 bpm (previously 115-120 bpm in the Micra AV1). Micra AV2 presents also a potential extended longevity of 15.6 years (increased by \> 44% in comparison of Micra AV1). Up to now, no clinical study has evaluated the efficacy and safety of Micra AV2 in a real-world setting. The focus of this study is to characterize chronic ambulatory AV synchrony in patients with high degree AV block and normal sinus rhythm implanted with a Micra AV2 as primary objective to evaluate AV synchrony during exercise as secondary objective.

Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry

The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.