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Wireless pacemaker shows promise for Dual-Chamber pacing

NCT ID NCT05252702

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new type of pacemaker that doesn't use wires (leads) to help both the upper and lower chambers of the heart beat in sync. It involved 464 people with slow heart rhythms who needed a pacemaker. The main goals were to see if the device was safe and worked well at 3 and 12 months 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
Aveir DR Leadless Pacemaker System (a device implanted in the heart to regulate heartbeat)
What this could lead to
If successful, this could offer a safer, less invasive option for people needing a dual-chamber pacemaker, potentially reducing complications from traditional pacemakers.
What could go wrong
This was a single study without a comparison group, so results may not apply to everyone. Complications like device-related serious events were tracked, and long-term benefits are not yet proven.

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

464 people

The number who actually took part.

Started

Feb 2022

Finished

Feb 2026

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 at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines 2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater 3. Subject has a life expectancy of at least one year 4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams 5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC Exclusion Criteria: 1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor 2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period 3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results 4. Subject has a known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU 5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis 6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments) 7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device 8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker) 9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators) 10. Subject is unable to read or write

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrioventricular block Bradycardia cardiac rhythm disease sick sinus syndrome Syncope, Vasovagal

As listed by the trial registrant

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

Bradycardia Cardiac pacemaker, artificial Cardiac rhythm disorder

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Amsterdam Academic Medical Centre (AMC)

    Amsterdam, 1105 AZ, Netherlands

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401, United States

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100, Italy

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Bryan Heart

    Lincoln, Nebraska, 68506, United States

  • CHRU Albert Michallon

    Grenoble, 38043, France

  • Cardiac Arrhythmia & Pacemaker Center

    Roslyn, New York, 11576, United States

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centro Cardiologico Monzino

    Milan, 20138, Italy

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720, United States

  • Donald Guthrie Foundation for Education & Research

    Sayre, Pennsylvania, 18840, United States

  • Emory University Hospital

    Atlanta, Georgia, 30342, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4N1, Canada

  • Franciscan Heart & Vascular Associates

    Tacoma, Washington, 98405, United States

  • HSC, Eastern Health

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

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Hopital d'adulte de la Timone

    Marseille, Alpes, 13005, France

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario de Badajoz

    Badajoz, Extmdra, 06080, Spain

  • Huntington Memorial Hospital

    Pasadena, California, 91105, United States

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

    Montreal, Quebec, Canada

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Jersey Shore University Medical Center

    Ocean City, New Jersey, 07712, United States

  • John Radcliffe Hospital

    Oxford, Soeast, OX3 9DU, United Kingdom

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Kepler Universitätsklinikum GmbH

    Linz, Upper Austria, 4021, Austria

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, Japan

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken, Japan

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Hermann Hospital

    The Woodlands, Texas, 77380, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Naples Heart Rhythm Specialists, PA

    Naples, Florida, 34119, United States

  • National Cerebral & Cardiovascular Center Hospital

    Suita, Osaka, Japan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Nemocnice Na Homolce

    Prague, Czechia

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • New York University Hospital

    New York, New York, 10016, United States

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Hospital South

    Oklahoma City, Oklahoma, 73135, United States

  • Pacific Heart Institute

    Santa Monica, California, 90404, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62769, United States

  • Premier Cardiology, Inc

    Newport Beach, California, 92663, United States

  • Prince of Wales Hospital

    Hong Kong, HK SAR, Hong Kong

  • Providence Hospital

    Southfield, Michigan, 48075, United States

  • Providence Medical Foundation

    Orange, California, 92868, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • QE II Health Sciences

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Queen Mary Hospital

    Hong Kong, HK SAR, Hong Kong

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57104, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • 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, L3Y2P9, Canada

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Tokyo Women's Medical University

    Tokyo, Japan

  • USC University Hospital

    Los Angeles, California, 90033, United States

  • UZ Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92118-8411, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.