Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

Implantable Defibrillator Clinical Trial

Official title: Evera MRI Clinical Study

Status Active, not recruiting

Clinical Trial Summary

The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Implantable Defibrillator

• NCT number: NCT02117414
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm Disease Management
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Completion date: October 2015