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

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).


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evera MRI Clinical Study
Enrollment: 275
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: MRI Group
- Sham Comparator: Control Group