Micra AV Transcatheter Pacing System Post-Approval Registry — Micra AV PAS  

Bradycardia Clinical Trial

Official title: Micra AV Transcatheter Pacing System Post-Approval Registry

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Bradycardia

• NCT number: NCT04253184
• Study type: Observational [Patient Registry]
• Source: Medtronic
• Status: Active, not recruiting
• Start date: February 8, 2020
• Completion date: April 2025