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Tiny pacemaker tested in 800 patients for safer heart pacing

NCT ID NCT04253184

Disease control Sponsor: Medtronic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracked 802 people with bradycardia (slow heart rate) who received a tiny, leadless pacemaker called Micra AV, implanted directly into the heart via a leg vein. The goal was to monitor safety and how well it provides synchronized pacing over 3 years. Researchers measured complication rates and pacemaker syndrome, a condition where the pacemaker causes discomfort.

What this could mean

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

Active substance
Micra AV Transcatheter Pacing System (miniaturized pacemaker implanted via catheter)
What this could lead to
If successful, this registry will confirm that the Micra AV pacemaker is safe and effective for long-term use in people with slow heart rates.
What could go wrong
This is an observational registry, not a randomized trial, so results may not prove superiority over other pacemakers. Complications like infection or device issues are possible.

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

802 people

The number who actually took part.

Started

Feb 2020

Finished

Jan 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.

Who is studied

Patients intended to be implanted with a Micra AV system are eligible for enrollment and all patients must be consented prior to the implant. As such, only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section). All patients enrolled and successfully implanted with a Micra AV system will be followed for a minimum of 3 years, unless a patient is exited from the registry due to an unavoidable reason. If a Micra AV system is not successfully implanted, patients will be exited from the registry unless a Micra AV System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient is intended to receive or be treated with a Micra AV Transcatheter Pacing System and must be enrolled prior to the implant procedure Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

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Conditions

The condition(s) this trial relates to.

Bradycardia

As listed by the trial registrant

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

Bradycardia

Contacts and locations

Locations

  • Akerhus University Hospital

    Oslo, Norway

  • Amsterdam UMC - Locatie AMC

    Amsterdam, Netherlands

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliera Sepdali Civili di Brescia

    Brescia, Italy

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, Italy

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Barzilai Medical Center Ashkelon

    Ashkelon, Israel

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHRU de Tours - Hopital trousseau

    Chambray-lès-Tours, France

  • CHU Toulouse - Hôpital Rangueil

    Toulouse, France

  • Cardiac Vascular Sentral Kuala Lumpur

    Kuala Lumpur, Malaysia

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Centre Hospitalier Régional de la Citadelle

    Liège, Belgium

  • Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

    Clermont-Ferrand, France

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Canada

  • Centro Cardiologico Monzino

    Milan, Italy

  • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

    Carnaxide, Portugal

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur

    Toulouse, France

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, Spain

  • Consultants in Cardiology

    Fort Worth, Texas, 76104, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California, 92270, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Forrest General Hospital

    Hattiesburg, Mississippi, 39404, United States

  • HagaZiekenhuis - Locatie Leyweg

    The Hague, Netherlands

  • Hospital Universitario da Coruña

    A Coruña, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Spain

  • Hygeia Hospital

    Athens, Greece

  • Hôpital Européen Georges-Pompidou

    Paris, France

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    Pessac, France

  • Indiana University Health Methodist Research Institute

    Indianapolis, Indiana, 46202, United States

  • Inselspital-Universitatsspital Bern

    Bern, Switzerland

  • Institut Jantung Negara

    Kuala Lumpur, Malaysia

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Canada

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • King Salman Heart Center - King Fahad Medical City

    Riyadh, Saudi Arabia

  • Klinicki Centar Srbije

    Belgrade, Serbia

  • Klinikum Villingen-Schwenningen

    Villingen-Schwenningen, Germany

  • Lankenau Institute for Medical Research

    Philadelphia, Pennsylvania, 19096, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Maria Cecilia Hospital

    Cotignola, Italy

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • MedStar Baltimore

    Baltimore, Maryland, 21204, United States

  • Medicor Associates

    Erie, Pennsylvania, 16507, United States

  • Metropolitan Cardiology Consultants

    Coon Rapids, Minnesota, 55433, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Monmouth Cardiology

    Ocean City, New Jersey, 07712, United States

  • Montreal Heart Institute

    Montreal, Canada

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Na Homolce Hospital

    Prague, Czechia

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10022, United States

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021, United States

  • Northampton General Hospital NHS Trust

    Northampton, United Kingdom

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Odense Universitetshospital

    Odense, Denmark

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma, 73120, United States

  • Robert Bosch Krankenhaus

    Stuttgart, Germany

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Saint Lukes Health System

    Kansas City, Missouri, 64111, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sequoia Hospital

    Redwood City, California, 94062, United States

  • Southampton General Hospital

    Southampton, United Kingdom

  • St. Vinzenz-Hospital Köln

    Cologne, Germany

  • Städtisches Klinikum Karlsruhe GmbH

    Karlsruhe, Germany

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The John Hopkins Hospital

    Baltimore, Maryland, 20817, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • TidalHealth Peninsula Regional Medical Center

    Salisbury, Maryland, 21804, United States

  • UZ Leuven-Campus - Campus Gasthuisberg

    Leuven, Belgium

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102, United States

  • Universitair Ziekenhuis Brussel

    Brussels, Belgium

  • University Medical Centre Ljubljana

    Ljubljana, Slovenia

  • University of Calgary

    Calgary, Canada

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160, United States

  • University of Pittsburgh Medical Center UPMC Shadyside

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • UniversitätsSpital Zürich

    Zurich, Switzerland

  • Universitätsklinikum Jena - Friedrich Schiller Universität

    Jena, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610, United States

  • Yale New Haven Health System

    New Haven, Connecticut, 06520, United States

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