Micra Transcatheter Pacing System Post-Approval Registry

  • STATUS
    Not Recruiting
  • End date
    Aug 23, 2026
  • participants needed
    3100
  • sponsor
    Medtronic
Updated on 2 February 2021
Investigator
Micra Registry Manager
Primary Contact
(0.0 mi away) Contact
+154 other location

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.

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.

Details
Condition Arrhythmia, Bradycardia, Dysrhythmia
Treatment Micra Transcatheter Pacing System
Clinical Study IdentifierNCT02536118
SponsorMedtronic
Last Modified on2 February 2021

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