Clinical Trial

Efficacy and Safety of Micra AV2 Transcatheter Pacing System

Study acronym: EMAV2
Recruiting
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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.
Trial Details
NCT Number NCT07356505
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: Medtronic
Conditions AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
Enrollment 150 participants
Start Date 2026-01-12
Primary Completion 2027-06-30 (estimated)
Study Completion 2029-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-21