RecruitingNot ApplicableNCT07356505

Efficacy and Safety of Micra AV2 Transcatheter Pacing System


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

150 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Implant procedure of a Micra AV2 leadless pacemaker (Medtronic) for people with av block, av block complete, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplant 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

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NCT07356505


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