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Belgo-Luxembourg Leadless PM Registry
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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
Official title: Belgo-Luxembourg Collaborative Research Network on AVEIR Leadless Pacemakers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-11-01
Completion Date
2028-11-01
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
CT scan heart
Acquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker
24 hour ambulatory ECG monitoring
24 hour ambulatory ECG monitoring
Locations (9)
University Hospitals of Leuven
Leuven, Flemish Brabant, Belgium
ZAS Middelheim
Antwerp, Belgium
UZ Brussel
Brussels, Belgium
Erasme ziekenhuis
Brussels, Belgium
AZ Maria Middelares
Ghent, Belgium
CHR Citadelle
Liège, Belgium
Domaine universitaire du Sart Tilman
Liège, Belgium
AZ Delta
Roeselare, Belgium
CHL Luxembourg
Luxembourg, Luxembourg