Micra Transcatheter Pacing System Post-Approval Registry

Bradycardia Clinical Trial

Official title: Micra Transcatheter Pacing System Post-Approval Registry

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bradycardia

• NCT number: NCT02536118
• Study type: Observational [Patient Registry]
• Source: Medtronic
• Status: Active, not recruiting
• Start date: July 2015
• Completion date: August 2025