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Wireless pacemaker takes on traditional device in heart study

NCT ID NCT05498376

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new leadless pacemaker (Micra AV) to a standard dual-chamber pacemaker in 100 patients aged 70 and older with heart block. The goal is to see if the leadless version works just as well for exercise capacity. Participants are randomly assigned to receive one of the two devices, and their exercise ability is measured after implantation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Leadless pacemaker (Micra AV) and conventional dual-chamber pacemaker
What this could lead to
If successful, this could show that a leadless pacemaker works as well as a traditional one for maintaining exercise ability, offering a less invasive option with fewer complications.
What could go wrong
This is a small, single-center trial with only 100 participants, so results may not apply to everyone. The leadless device may not match the conventional one in performance, and long-term benefits are still uncertain.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

Aug 2022

Expected to finish

Dec 2027

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

70 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: * Patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent AV block, qualifying for a conventional or leadless pacemaker * Written informed consent Exclusion Criteria: * Permanent atrial fibrillation or atrial standstill * Evidence of sinus node disease and need for right atrial pacing (not possible with Micra AV) * LVEF \<50% and permanent high-degree or total AVB (requiring CRT/His-Bundle/CSP pacing) * Preoperative E/A ratio \>1.5 in the echocardiography * Any co-existing ICD indications (no leadless ICD systems available) * Hemodialysis * Presence of a mechanical tricuspid valve prosthesis * Unwilling or unable to comply fully with study procedures and follow-up

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrioventricular block Bradycardia cardiac rhythm disease cardiovascular disorder heart disorder

As listed by the trial registrant

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

Arrhythmias, cardiac Cardiac pacemaker Cardiovascular diseases Heart diseases

Contacts and locations

Locations

  • Inselspital, Bern University Hospital

    Bern, 3010, Switzerland

More trials for these conditions

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