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Tiny leadless pacemaker tested against wired version in seniors

NCT ID NCT05856799

Disease control Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new leadless pacemaker (Micra AV) is better than a traditional wired pacemaker for people aged 75 and older with heart block. The goal is to see if the leadless device improves quality of life, patient acceptance, and exercise ability. Eighty participants will be randomly assigned to receive one of the two pacemakers and will be followed for up to 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing \>80% of the time, * Age 75 years or older * Intact sinus node function * Expected survival more than 12 months based on clinical evaluation * Able to provide informed consent Exclusion criteria: * Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT. * Persistent, or chronic atrial fibrillation * Reversible AVB * Transient AVB due to ongoing ischemia * Heart failure NYHA class III-IV * Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class * Indication for primary or secondary prophylactic ICD implantation * Acute myocardial infarction (AMI) within 3 months * Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity * Expected survival \< 12 months based on clinical evaluation * Performing high intensity sport * Participation in another trial with experimental treatment * Contraindication against device implantation (e.g., concurrent infection) * Failure to provide informed consent

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Conditions

The condition(s) this trial relates to.

atrioventricular block heart disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Av block

Contacts and locations

Locations

  • Department of Cardiology Aarhus University Hospital

    Aarhus, Region Midt, 8200, Denmark

  • Department of Cardiology Odense University Hospital

    Odense, Region Syd, 5000, Denmark

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