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

AV Block AV Block Complete AV Block-2Nd Degree-Type 1

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

Inclusion Criteria5

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
At least 18 years of age at the time of signing the Informed Consent Form (ICF)
Participant will be implanted with a Micra AV2 for an approved indication for use
Participant with a history of any type of high-degree AV block
Participant is willing and able to comply the study protocol

Exclusion Criteria1

Subject implanted with a Micra AV2 on a non-permanent basis (e.g. CIED infection) 2. Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to Micra AV2 implant procedure) 3. Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study.

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