AV Block CompleteEMAV2NCT07356505
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
A study testing Implant procedure of a Micra AV2 leadless pacemaker (Medtronic) in people with AV Block Complete and AV Block-2Nd Degree-Type 1, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
- What is being tested?
- Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals of Leuven
Leuven, Flemish Brabant, 3000
Christophe Garweg, Prof.essor, +3216344248, christophe.garweg@uzleuven.be
Patricia Poels, PhD, +3216340462, patricia.poels@uzleuven.be
About this study
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.
Read the detailed description
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):
- Characterize the AV synchrony and device behaviour during exercise in subjects with persistent third degree AV block and normal sinus node function at 6-month post implant procedure
- Characterize the evolution of left ventricular function at 12-month post implant
- Evaluate the efficacy of the 'Atrial Sensing Setup' at the end of the implant procedure
- Long-term follow-up (3 years) to evaluate AV synchrony, need for system revision and complication rate including rate of pacing induced cardiomyopathy
- Conditions
- AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
- Being tested
- Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
- Keywords
- leadless pacemaker, Micra AV, AV synchrony
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)Device
All patients will be implanted with aMicra AV2 leadless pacemaker
| Study group | Role | What they receive |
|---|---|---|
| Micra AV | Experimental | All patients will receive a Micra AV2 leadless pacemaker Receives: Device: Implant procedure of a Micra AV2 leadless pacemaker (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start12 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV Block CompleteStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356505
- Sponsor's protocol ID
- s70117
- Acronym
- EMAV2
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Micra AV2 Transcatheter Pacing System
- ClinicalTrials.gov ID
- NCT07356505
- Acronym / sponsor ID
- EMAV2 / s70117
- Conditions
- AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
- Keywords
- leadless pacemaker, Micra AV, AV synchrony
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
- Characterize the AV synchrony and device behaviour during exercise in subjects with persistent third degree AV block and normal sinus node function at 6-month post implant procedure
- Characterize the evolution of left ventricular function at 12-month post implant
- Evaluate the efficacy of the 'Atrial Sensing Setup' at the end of the implant procedure
- Long-term follow-up (3 years) to evaluate AV synchrony, need for system revision and complication rate including rate of pacing induced cardiomyopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micra AV | Experimental | Device: Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)All patients will receive a Micra AV2 leadless pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)All patients will be implanted with aMicra AV2 leadless pacemaker | Device | Micra AV |
Primary outcome
AV synchrony at 6 months
Time frame: 6 months follow-up
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant procedure of a Micra AV2 leadless pacemaker (Medtronic) in people with AV Block Complete and AV Block-2Nd Degree-Type 1, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Y Garweg, Professor (+32163444248, christophe.garweg@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AV synchrony at 6 months (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.