An interventional study of Implant procedure of a Micra AV2 leadless pacemaker (Medtronic) in AV Block Complete, AV Block-2Nd Degree-Type 1 and AV Block, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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.
Prospective, single-arm, multi-centre clinical study to characterize the chronic efficacy and safety profile of CE approved and market released Micra AV2 A sample size of approximately 150 subjects implanted with a Micra AV2 is required to evaluate the different objectives. A minimal sample size of 50 subjects with persistent 3rd degree AVB and normal sinus node function is required to evaluate the ambulatory AV synchrony at 6-month follow-up.
Primary objective:
Characterize ambulatory AV synchrony in subjects with persistent third degree AV block and normal sinus node function at 6-month post Micra AV2 implant procedure
Secondary objective(s):
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 150 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive a Micra AV2 leadless pacemaker
Device: Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
All patients will be implanted with aMicra AV2 leadless pacemaker
AV synchrony at 6 months
AV synchrony will be computed on an individual heartbeat basis and is defined as met for paced or sensed ventricular beats that are within 300 ms following an ECG confirmed P-wave. This endpoint will be used for the primary objective , for the secondary objective #1 (AV synchrony during exercise at 6-month post-implant) and for the secondary objective #3 (evaluation of the AV synchrony following the automated atrial sensing setup)
Time frame: 6 months follow-up
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