NCT04253184

Micra AV Transcatheter Pacing System Post-Approval Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 802 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Detailed description

The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent). Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Micra AV Transcatheter Pacing System	The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.

Timeline

• Start date: 2020-02-08
• Primary completion: 2025-09-05
• Completion: 2026-01-14
• First posted: 2020-02-05
• Last updated: 2026-02-04

Locations

89 sites across 20 countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Malaysia, Netherlands, Norway, Portugal, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom