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Efficacy and Safety of Micra AV2 Transcatheter Pacing System

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT07356505 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Participant will be implanted with a Micra AV2 for an approved indication for use 4. Participant with a history of any type of high-degree AV block 5. Participant is willing and able to comply the study protocol Exclusion Criteria: -1. 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. 4\. Subject meets any exclusion criteria required by local law (age or other)
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What it tests

  • Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
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Where

1 site
University Hospitals of Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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