Micra Transcatheter Pacing System Post-Approval Registry



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:1/20/2019
Start Date:July 2015
End Date:August 2026
Contact:Micra Registry Manager
Email:rs.productsurveillanceregistry@medtronic.com

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
53
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