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Wireless pacemaker shows promise in large trial

NCT ID NCT04559945

Disease control Sponsor: Abbott Medical Devices 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new type of pacemaker that doesn't need wires (leads) to connect to the heart. It was implanted directly into the heart in over 1,200 people with slow heart rhythms. The goal was to see if it is safe and works well. The study found that most patients had no serious complications and the device performed as expected.

What this could mean

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

Active substance
Aveir VR Leadless Pacemaker System (a small, wire-free pacemaker implanted directly in the heart)
What this could lead to
If successful, this could offer a safer, less invasive option for people with slow heart rhythms, reducing complications from traditional pacemaker leads.
What could go wrong
This is a completed study, but results may not apply to all patients. Risks include device-related serious adverse events, and long-term performance beyond the study period is still being monitored.

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

1,276 people

The number who actually took part.

Started

Nov 2020

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

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. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including: * Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or * Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or * Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and 2. Subject is ≥18 years of age; and 3. Subject has a life expectancy of at least one year; and 4. Subject is not enrolled in another clinical investigation; and 5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and 7. Subject is not pregnant and does not plan to get pregnant during the course of the study. Exclusion Criteria: 1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. Subject is allergic or hypersensitive to \< 1 mg of dexamethasone sodium phosphate (DSP); 3. Subject has a mechanical tricuspid valve prosthesis; or 4. Subject has a pre-existing endocardial pacing or defibrillation leads; or 5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or 6. Subject has an implanted vena cava filter; or 7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or 9. Subject has an implanted leadless cardiac pacemaker or 10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac Bradycardia cardiac rhythm disease

As listed by the trial registrant

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

Bradycardia Cardiac rhythm disorder

Contacts and locations

Locations

  • Amsterdam Academic Medical Centre (AMC)

    Amsterdam, Netherlands

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • CHRU Albert Michallon

    Grenoble, France

  • CHRU Hopital de Pontchaillou

    Rennes, France

  • Cardiac Arrhythmia & Pacemaker Center

    Roslyn, New York, 11576, United States

  • Centro Cardiologico Monzino

    Milan, Italy

  • Cone Health Medical Group HeartCare

    Greensboro, North Carolina, 27401, United States

  • Foothills Medical Centre

    Calgary, Alberta, Canada

  • HSC, Eastern Health

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Honor Health

    Scottsdale, Arizona, 85258, United States

  • Hopital d'adulte de la Timone

    Marseille, France

  • Hospital Universitario Infanta Cristina

    Badajoz, 6080, Spain

  • Huntington Memorial Hospital

    Pasadena, California, 91105, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, Canada

  • Institut de Cardiologie de Quebec (Hospital Laval)

    Québec, Quebec, Canada

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Isala - ZWolle

    Zwolle, Netherlands

  • Jersey Shore University Medical Center

    Ocean Township, New Jersey, 07712, United States

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Kinsgston General Hospital

    Kingston, Ontario, Canada

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Hermann Hospital

    The Woodlands, Texas, 77380, United States

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141, United States

  • Methodist University Hospital

    Memphis, Tennessee, 38104, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • Na Homolce Hospital

    Prague, 150 30, Czechia

  • Naples Heart Rhythm Specialists PA

    Naples, Florida, 34119, United States

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30306, United States

  • Premier Cardiology Inc

    Newport Beach, California, 92663, United States

  • Redmond Regional Medical Center

    Rome, Georgia, 30165, United States

  • Royal Brompton Hospital

    London, United Kingdom

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120, United States

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201, United States

  • Southlake Regional Health Centre

    Newmarket, Ontario, Canada

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St. Elizabeth Medical Center - South Unit

    Edgewood, Kentucky, 41017, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Heart Center PC

    Huntsville, Alabama, 35801, United States

  • University Hospital - University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California

    Long Beach, California, 90803, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • WellSpan Health

    York, Pennsylvania, 17405, United States

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