NCT02536118

Micra Transcatheter Pacing System Post-Approval Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,100 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2015-08-31
• Last updated: 2026-02-04

Locations

156 sites across 24 countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom