Last updated on October 2017

Micra Transcatheter Pacing System Post-Approval Registry


Brief description of study

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.

Detailed Study Description

The Micra Registry is a global, prospective, observational, multi-site registry. All patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post implant or until registry closure. 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.

Clinical Study Identifier: NCT02536118

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