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Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-01-12
Completion Date
2029-01-31
Last Updated
2026-01-21
Healthy Volunteers
No
Interventions
Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
All patients will be implanted with aMicra AV2 leadless pacemaker
Locations (1)
University Hospitals of Leuven
Leuven, Flemish Brabant, Belgium