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NOT YET RECRUITING
NCT07879716
NA

Belgo-Luxembourg Leadless PM Registry

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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

Interventions

RADIATION

CT scan heart

Acquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker

DIAGNOSTIC_TEST

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