Micra Transcatheter Pacing System Post-Approval Registry
1 other identifier
observational
3,100
24 countries
156
Brief Summary
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 4, 2026
January 1, 2026
11.8 years
August 17, 2015
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Acute complication rate
To estimate acute complication rate related to the Micra system and/or implant procedure.
30-days
Long-term complication free survival
To estimate the chronic complication free survival rate of the Micra system.
9 years
Secondary Outcomes (5)
Pacing impedance (ohms) and pacing threshold (volts)
Up to 9 years
Complications stratified by implant type
Up to 9 years
Estimate Micra System revision rate
Up to 9 years
Estimate System Longevity
Up to 9 years
Confirm the rate response operation of the Micra system
Approximately 2 years
Other Outcomes (1)
Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment
Up to 9 years
Study Arms (1)
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Interventions
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.
Eligibility Criteria
Patients intended to be implanted with a Micra system are eligible for enrollment and all patients must be consented prior to the implant. 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 system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra 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.
You may qualify if:
- 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 Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (156)
Unknown Facility
Birmingham, Alabama, United States
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Los Angeles, California, United States
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Redwood City, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Safety Harbor, Florida, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, 46202, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Edgewood, Kentucky, United States
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Louisville, Kentucky, United States
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Salisbury, Maryland, United States
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Silver Spring, Maryland, United States
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Takoma Park, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Lansing, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Morristown, New Jersey, United States
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Ridgewood, New Jersey, United States
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Huntington, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Milwaukee, Wisconsin, United States
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Kingston, Ontario, Canada
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Montreal, Canada
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Prague, Czechia
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Aarhus, Denmark
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Copenhagen, Denmark
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Hillerød, Denmark
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Odense, Denmark
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Annecy, France
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Bayonne, France
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Bordeaux, France
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Brest, France
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Chambray-lès-Tours, France
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Clermont-Ferrand, France
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Grenoble, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nancy, France
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Nantes, France
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Neuilly-sur-Seine, France
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Rennes, France
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Rouen, France
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Saint-Denis, France
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Saint-Etienne, France
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Strasbourg, France
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Toulouse, France
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Villeurbanne, France
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Aachen, Germany
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Berlin, Germany
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Cologne, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Jena, Germany
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Mainz, Germany
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Münster, Germany
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Tübingen, Germany
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Ulm, Germany
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Athens, Greece
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Marousi, Greece
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Budapest, Hungary
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Reykjavik, Iceland
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Ashkelon, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Bari, Italy
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Bologna, Italy
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Brescia, Italy
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Cotignola, Italy
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Milan, Italy
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Pisa, Italy
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Roma, Italy
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Mitaka-shi, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Suita, Japan
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Yokohama, Japan
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Safat, Kuwait
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Amsterdam, Netherlands
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Breda, Netherlands
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Eindhoven, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Christchurch, New Zealand
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Bergen, Norway
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Trondheim, Norway
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Poznan, Poland
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Zabrze, Poland
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Lisbon, Portugal
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Jeddah, Saudi Arabia
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Riyadh, Saudi Arabia
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A Coruña, Spain
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Barcelona, Spain
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Santiago de Compostela, Spain
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Toledo, Spain
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Vitoria-Gasteiz, Spain
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Uppsala, Sweden
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Basel, Switzerland
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Bern, Switzerland
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Fribourg, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Lugano, Switzerland
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Zurich, Switzerland
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Leeds, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Nottingham, United Kingdom
Unknown Facility
Southampton, United Kingdom
Related Publications (5)
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.
PMID: 35025987DERIVEDEl-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.
PMID: 34757189DERIVEDEl-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.
PMID: 33428248DERIVEDGarg 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.
PMID: 32763431DERIVEDEl-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.
PMID: 30103071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Micra Registry Manager
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 31, 2015
Study Start
July 1, 2015
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 4, 2026
Record last verified: 2026-01