NCT01110915

Advisa MRI Clinical Study

Advisa MRI™ System Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam. Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.

Conditions

• Magnetic Resonance Imaging
• Cardiac Pacemaker, Artificial

Interventions

Type	Name	Description
DEVICE	Medtronic Advisa MRI Implantable Pulse Generator (IPG)	Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
DEVICE	Medtronic CapSureFix MRI™ active fixation MRI lead	The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-03-01
• Completion: 2013-03-01
• First posted: 2010-04-27
• Last updated: 2013-04-30
• Results posted: 2013-04-04

Locations

37 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Switzerland, United Kingdom