Micra AV Transcatheter Pacing System Post-Approval Registry
NCT ID: NCT04253184
Last Updated: 2025-10-20
Study Results
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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ACTIVE_NOT_RECRUITING
802 participants
OBSERVATIONAL
2020-02-08
2026-01-30
Brief Summary
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The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
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Detailed Description
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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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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
* 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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
ALL
No
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States
Sequoia Hospital
Redwood City, California, United States
Yale New Haven Health System
New Haven, Connecticut, United States
Baptist Health
Jacksonville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Indiana University Health Methodist Research Institute
Indianapolis, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
The John Hopkins Hospital
Baltimore, Maryland, United States
MedStar Baltimore
Baltimore, Maryland, United States
TidalHealth Peninsula Regional Medical Center
Salisbury, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Heart
Ypsilanti, Michigan, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Forrest General Hospital
Hattiesburg, Mississippi, United States
Saint Lukes Health System
Kansas City, Missouri, United States
Monmouth Cardiology
Ocean City, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Medicor Associates
Erie, Pennsylvania, United States
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Consultants in Cardiology
Fort Worth, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Universitair Ziekenhuis Brussel
Brussels, , Belgium
UZ Leuven-Campus - Campus Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Régional de la Citadelle
Liège, , Belgium
University of Calgary
Calgary, , Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, , Canada
Montreal Heart Institute
Montreal, , Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, , Canada
Na Homolce Hospital
Prague, , Czechia
Odense Universitetshospital
Odense, , Denmark
CHRU de Tours - Hopital trousseau
Chambray-lès-Tours, , France
Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied
Clermont-Ferrand, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, , France
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
St. Vinzenz-Hospital Köln
Cologne, , Germany
Universitätsklinikum Jena - Friedrich Schiller Universität
Jena, , Germany
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe, , Germany
Robert Bosch Krankenhaus
Stuttgart, , Germany
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Hygeia Hospital
Athens, , Greece
Barzilai Medical Center Ashkelon
Ashkelon, , Israel
Azienda Ospedaliera Sepdali Civili di Brescia
Brescia, , Italy
Maria Cecilia Hospital
Cotignola, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur, , Malaysia
Institut Jantung Negara
Kuala Lumpur, , Malaysia
Amsterdam UMC - Locatie AMC
Amsterdam, , Netherlands
HagaZiekenhuis - Locatie Leyweg
The Hague, , Netherlands
Akerhus University Hospital
Oslo, , Norway
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide, , Portugal
King Salman Heart Center - King Fahad Medical City
Riyadh, , Saudi Arabia
Klinicki Centar Srbije
Belgrade, , Serbia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Hospital Universitario da Coruña
A Coruña, , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Inselspital-Universitatsspital Bern
Bern, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Northampton General Hospital NHS Trust
Northampton, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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Micra AV PAS
Identifier Type: -
Identifier Source: org_study_id
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