Advisa

The purpose of the Advisa MRI™ System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

Advisa [NCT01110915]

Description: The purpose of the Advisa MRI™ System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

Device: Medtronic Advisa MRI™ Pacing System

Primary Investigator: Schloss

Drug/Device Information
Medtronic Advisa MRI™ pacing system
Evaluate the safety and effectiveness when used in MRI scans up to 2W/kg specific absorption rate
Medtronic
Major Inclusion and Exclusion
Class I or II indication for dual chamber pacemaker
No prior pacemaker or ICD
Randomized to MRI or control at 9 weeks