Micra AV2 leadless pacemaker to improve AV synchrony in AV block
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Flemish Brabant) |
| Trial ID | NCT07356505 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven, Flemish Brabant
- University Hospitals of Leuven — Leuven, Flemish Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Christophe Y Garweg, Professor
- Email: christophe.garweg@uzleuven.be
- Phone: +32163444248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.