NCT07356505

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

January 12, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

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

Keywords

leadless pacemakerMicra AVAV synchrony

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months follow-up

Study Arms (1)

Micra AV

EXPERIMENTAL

All patients will receive a Micra AV2 leadless pacemaker

Device: Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)

Interventions

Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)DEVICE

All patients will be implanted with aMicra AV2 leadless pacemaker

Micra AV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Y Garweg, Professor

CONTACT

+32163444248christophe.garweg@uzleuven.be

Caroline Devooght, Miss

CONTACT

+3216344248caroline.devooght@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 31, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

BE(1)