Micra Transcatheter Pacing System Post-Approval Registry
NCT ID: NCT02536118
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
3100 participants
OBSERVATIONAL
2015-07-31
2027-04-30
Brief Summary
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The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
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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 system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.
\*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Interventions
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Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS 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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Principal Investigators
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Micra Registry Manager
Role: STUDY_DIRECTOR
Medtronic
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Redwood City, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Safety Harbor, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
West Des Moines, Iowa, United States
Kansas City, Kansas, United States
Edgewood, Kentucky, United States
Louisville, Kentucky, United States
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Lansing, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Saint Cloud, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Morristown, New Jersey, United States
Ridgewood, New Jersey, United States
Huntington, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Kingston, Ontario, Canada
Montreal, , Canada
Prague, , Czechia
Aarhus, , Denmark
Copenhagen, , Denmark
Hillerød, , Denmark
Odense, , Denmark
Annecy, , France
Bayonne, , France
Bordeaux, , France
Brest, , France
Chambray-lès-Tours, , France
Clermont-Ferrand, , France
Grenoble, , France
Lille, , France
Marseille, , France
Montpellier, , France
Nancy, , France
Nantes, , France
Neuilly-sur-Seine, , France
Rennes, , France
Rouen, , France
Saint-Denis, , France
Saint-Etienne, , France
Strasbourg, , France
Toulouse, , France
Villeurbanne, , France
Aachen, , Germany
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Jena, , Germany
Mainz, , Germany
Münster, , Germany
Tübingen, , Germany
Ulm, , Germany
Athens, , Greece
Marousi, , Greece
Budapest, , Hungary
Reykjavik, , Iceland
Ashkelon, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Bari, , Italy
Bologna, , Italy
Brescia, , Italy
Cotignola, , Italy
Milan, , Italy
Pisa, , Italy
Roma, , Italy
Mitaka-shi, Tokyo, Japan
Shinagawa, Tokyo, Japan
Suita, , Japan
Yokohama, , Japan
Safat, , Kuwait
Amsterdam, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Maastricht, , Netherlands
Nieuwegein, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Christchurch, , New Zealand
Bergen, , Norway
Trondheim, , Norway
Poznan, , Poland
Zabrze, , Poland
Lisbon, , Portugal
Jeddah, , Saudi Arabia
Riyadh, , Saudi Arabia
A Coruña, , Spain
Barcelona, , Spain
Santiago de Compostela, , Spain
Toledo, , Spain
Vitoria-Gasteiz, , Spain
Uppsala, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Fribourg, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Lugano, , Switzerland
Zurich, , Switzerland
Birmingham, , United Kingdom
Bristol, , United Kingdom
Leeds, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Nottingham, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.
El-Chami MF, Garweg C, Iacopino S, Al-Samadi F, Martinez-Sande JL, Tondo C, Johansen JB, Prat XV, Piccini JP, Cha YM, Grubman E, Bordachar P, Roberts PR, Soejima K, Stromberg K, Fagan DH, Clementy N. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2022 Feb;19(2):228-234. doi: 10.1016/j.hrthm.2021.10.023. Epub 2021 Oct 29.
El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.
Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Vinolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.
Other Identifiers
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Micra Registry
Identifier Type: -
Identifier Source: org_study_id
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