Micra Transcatheter Pacing System Post-Approval Registry

February 2, 2026 updated by: Medtronic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*.

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.

Study Type

Observational

Enrollment (Actual)

3100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
      • Edegem, Belgium
      • Leuven, Belgium
  • Canada
      • Montreal, Canada
    • Ontario
      • Kingston, Ontario, Canada
  • Czechia
      • Prague, Czechia
  • Denmark
      • Aarhus, Denmark
      • Copenhagen, Denmark
      • Hillerød, Denmark
      • Odense, Denmark
  • France
      • 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
  • Germany
      • 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
  • Greece
      • Athens, Greece
      • Marousi, Greece
  • Hungary
      • Budapest, Hungary
  • Iceland
      • Reykjavik, Iceland
  • Israel
      • Ashkelon, Israel
      • Jerusalem, Israel
      • Ramat Gan, Israel
  • Italy
      • Bari, Italy
      • Bologna, Italy
      • Brescia, Italy
      • Cotignola, Italy
      • Milan, Italy
      • Pisa, Italy
      • Roma, Italy
  • Japan
      • Suita, Japan
      • Yokohama, Japan
    • Tokyo
      • Mitaka-shi, Tokyo, Japan
      • Shinagawa, Tokyo, Japan
  • Kuwait
      • Safat, Kuwait
  • Netherlands
      • Amsterdam, Netherlands
      • Breda, Netherlands
      • Eindhoven, Netherlands
      • Enschede, Netherlands
      • Groningen, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
      • The Hague, Netherlands
  • New Zealand
      • Christchurch, New Zealand
  • Norway
      • Bergen, Norway
      • Trondheim, Norway
  • Poland
      • Poznan, Poland
      • Zabrze, Poland
  • Portugal
      • Lisbon, Portugal
  • Saudi Arabia
      • Jeddah, Saudi Arabia
      • Riyadh, Saudi Arabia
  • Spain
      • A Coruña, Spain
      • Barcelona, Spain
      • Santiago de Compostela, Spain
      • Toledo, Spain
      • Vitoria-Gasteiz, Spain
  • Sweden
      • Uppsala, Sweden
  • Switzerland
      • Basel, Switzerland
      • Bern, Switzerland
      • Fribourg, Switzerland
      • Geneva, Switzerland
      • Lausanne, Switzerland
      • Lugano, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Los Angeles, California, United States
      • Redwood City, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States
    • Florida
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Safety Harbor, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Louisville, Kentucky, United States
    • Maryland
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Lansing, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
      • Saint Cloud, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
    • New Jersey
      • Morristown, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New York
      • Huntington, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Transcatheter Pacing System and must be enrolled prior to the TPS 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Device: 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 Names:
  • Micra
  • Micra TPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute complication rate
Time Frame: 30-days
To estimate acute complication rate related to the Micra system and/or implant procedure.
30-days
Long-term complication free survival
Time Frame: 9 years
To estimate the chronic complication free survival rate of the Micra system.
9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pacing impedance (ohms) and pacing threshold (volts)
Time Frame: Up to 9 years
Summary statistics of electrical performance 5-years post-implant measurements will be reported.
Up to 9 years
Complications stratified by implant type
Time Frame: Up to 9 years
A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.
Up to 9 years
Estimate Micra System revision rate
Time Frame: Up to 9 years
Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
Up to 9 years
Estimate System Longevity
Time Frame: Up to 9 years
Summary statistics regarding battery length will be reported.
Up to 9 years
Confirm the rate response operation of the Micra system
Time Frame: Approximately 2 years
Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).
Approximately 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment
Time Frame: Up to 9 years
Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.
Up to 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Study Director: Micra Registry Manager, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimated)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Micra Registry

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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