Micra AV2 leadless pacemaker to improve AV synchrony in AV block
Official title: Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Run by Universitaire Ziekenhuizen KU Leuven · NCT07356505 · Data updated 2026-11-12
This study will test whether the Micra AV2 leadless pacemaker improves AV synchrony and is safe for adults with high‑degree AV block who have normal sinus rhythm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Flemish Brabant) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | January 31, 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07356505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a history of high‑degree AV block who are implanted with a Micra AV2 for an approved indication and have preserved sinus node function are the intended participants.
✕Probably not a fit
Patients with non‑permanent implants (for example due to active infection), significant sinus‑node dysfunction or pacing needs requiring atrial pacing or other device types may not receive benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single‑arm, multi‑center study enrolling about 150 adults implanted with the CE‑approved Micra AV2 leadless pacemaker, with a minimum cohort of 50 subjects who have persistent third‑degree AV block and normal sinus node function. The primary endpoint is ambulatory AV synchrony at six months post‑implant, with secondary evaluations of AV synchrony during exercise, left ventricular function at 12 months, peri‑implant atrial sensing setup efficacy, and a three‑year follow‑up for revisions and complications. All participants will undergo the Micra AV2 implant procedure and scheduled follow‑up visits including ambulatory monitoring and echocardiography. The device features updated AV synchrony algorithms and an increased projected longevity compared with the prior Micra AV generation.
Why it matters
Potential benefit: If successful, the Micra AV2 could give patients better AV synchrony during activity, longer device longevity, and the advantages of a leadless system such as fewer lead‑related complications.
How similar studies have gone: Earlier Micra AV devices have shown promising AV synchrony in prior clinical work, but the Micra AV2's higher tracking rate and extended longevity have not yet been evaluated in a real‑world clinical cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
University Hospitals of Leuven
Leuven, Flemish Brabant, Belgium Recruiting
Study contacts
- Study coordinator: Christophe Y Garweg, Professor
- Email: christophe.garweg@uzleuven.be
- Phone: +32163444248
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.