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Tiny pacemaker, big promise: could a leadless device simplify heart pacing?

NCT ID NCT07638995

Disease control Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a small, leadless pacemaker placed in the heart's upper chamber (atrium) for people with sinus node dysfunction, a condition where the heart's natural pacemaker doesn't work properly. Participants receive the Aveir AR pacemaker and a loop recorder to track heart rhythms. The goal is to see how often new atrial fibrillation occurs and whether a more complex two-chamber pacemaker becomes necessary over time.

What this could mean

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

Active substance
Aveir AR leadless pacemaker (Abbott)
What this could lead to
If successful, this approach could offer a less invasive pacing option for sinus node dysfunction, potentially reducing complications and preserving battery life compared to dual-chamber systems.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply broadly. Risks include device-related complications, new atrial fibrillation, or the need for a more complex dual-chamber system later.

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.

Participants

About 50 people

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

Started

May 2026

Expected to finish

Dec 2029

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.

Who is studied

1. 50 patients who receive an Aveir AR device as standard of care 2. Patients willing to receive an Assert-IQ loop recorder for research purposes 3. All sexes 4. Age \> 18 years old 5. Able to provide written informed consent

Ages

18 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: 1. Symptomatic sinus bradycardia 2. Sino-atrial exit block 3. Symptomatic sinus arrest with sinus pauses \> 2 sec during waking hours 4. Symptomatic sinus bradycardia \< 40 bpm for \> 1 min during waking hours 5. PR interval ≤ 0.22 sec if aged \< 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years 6. QRS width ≤ 0.12 sec 7. No prior PM implantation 8. Patients willing to receive an Assert-IQ loop recorder for research purposes Exclusion Criteria: 1. Atrioventricular block 2. Bundle branch block 3. History of atrial fibrillation 4. Carotid sinus hypersensitivity 5. Planned cardiac surgery 6. Estimated life expectancy \< 1 year 7. Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator 8. Known acute deep vein thrombosis of either lower extremity 9. Unable to read or write 10. Patient with Limited English Proficiency (LEP) 11. Cognitively impaired individuals 12. Pregnant

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Conditions

The condition(s) this trial relates to.

atrial fibrillation sick sinus syndrome

As listed by the trial registrant

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

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huntington Hospital

    RECRUITING

    Huntington, New York, 11743, United States

  • Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Long Island Jewish Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • South Shore University Hospital

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Staten Island University Hospital

    RECRUITING

    Staten Island, New York, 10305, United States

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