Micra AV Transcatheter Pacing System Post-Approval Registry

NCT ID: NCT04253184

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

802 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-08

Study Completion Date

2026-01-30

Brief Summary

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Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Detailed Description

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The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent).

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years

Conditions

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Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Micra AV Transcatheter Pacing System

The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.

Intervention Type DEVICE

Eligibility Criteria

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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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Eisenhower Desert Cardiology Center

Rancho Mirage, California, United States

Site Status

Sequoia Hospital

Redwood City, California, United States

Site Status

Yale New Haven Health System

New Haven, Connecticut, United States

Site Status

Baptist Health

Jacksonville, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Indiana University Health Methodist Research Institute

Indianapolis, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Site Status

Saint Elizabeth Healthcare

Edgewood, Kentucky, United States

Site Status

The John Hopkins Hospital

Baltimore, Maryland, United States

Site Status

MedStar Baltimore

Baltimore, Maryland, United States

Site Status

TidalHealth Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Michigan Heart

Ypsilanti, Michigan, United States

Site Status

Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

Site Status

United Heart and Vascular Clinic

Saint Paul, Minnesota, United States

Site Status

Forrest General Hospital

Hattiesburg, Mississippi, United States

Site Status

Saint Lukes Health System

Kansas City, Missouri, United States

Site Status

Monmouth Cardiology

Ocean City, New Jersey, United States

Site Status

The Valley Hospital

Ridgewood, New Jersey, United States

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Northwell Health

Manhasset, New York, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Site Status

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

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The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

Medicor Associates

Erie, Pennsylvania, United States

Site Status

Lankenau Institute for Medical Research

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center UPMC Shadyside

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Consultants in Cardiology

Fort Worth, Texas, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Site Status

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

UZ Leuven-Campus - Campus Gasthuisberg

Leuven, , Belgium

Site Status

Centre Hospitalier Régional de la Citadelle

Liège, , Belgium

Site Status

University of Calgary

Calgary, , Canada

Site Status

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, , Canada

Site Status

Montreal Heart Institute

Montreal, , Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, , Canada

Site Status

Na Homolce Hospital

Prague, , Czechia

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Odense Universitetshospital

Odense, , Denmark

Site Status

CHRU de Tours - Hopital trousseau

Chambray-lès-Tours, , France

Site Status

Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

Clermont-Ferrand, , France

Site Status

Hôpital Européen Georges-Pompidou

Paris, , France

Site Status

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, , France

Site Status

CHU Toulouse - Hôpital Rangueil

Toulouse, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

St. Vinzenz-Hospital Köln

Cologne, , Germany

Site Status

Universitätsklinikum Jena - Friedrich Schiller Universität

Jena, , Germany

Site Status

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, , Germany

Site Status

Robert Bosch Krankenhaus

Stuttgart, , Germany

Site Status

Klinikum Villingen-Schwenningen

Villingen-Schwenningen, , Germany

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Hygeia Hospital

Athens, , Greece

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Barzilai Medical Center Ashkelon

Ashkelon, , Israel

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Azienda Ospedaliera Sepdali Civili di Brescia

Brescia, , Italy

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Maria Cecilia Hospital

Cotignola, , Italy

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Centro Cardiologico Monzino

Milan, , Italy

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Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

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Cardiac Vascular Sentral Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Site Status

Amsterdam UMC - Locatie AMC

Amsterdam, , Netherlands

Site Status

HagaZiekenhuis - Locatie Leyweg

The Hague, , Netherlands

Site Status

Akerhus University Hospital

Oslo, , Norway

Site Status

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

Carnaxide, , Portugal

Site Status

King Salman Heart Center - King Fahad Medical City

Riyadh, , Saudi Arabia

Site Status

Klinicki Centar Srbije

Belgrade, , Serbia

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Hospital Universitario da Coruña

A Coruña, , Spain

Site Status

Hospital de la Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status

Inselspital-Universitatsspital Bern

Bern, , Switzerland

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Northampton General Hospital NHS Trust

Northampton, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia Denmark France Germany Greece Israel Italy Malaysia Netherlands Norway Portugal Saudi Arabia Serbia Slovenia Spain Switzerland United Kingdom

Other Identifiers

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Micra AV PAS

Identifier Type: -

Identifier Source: org_study_id

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