CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 269 enrolled
Drug / intervention
Medtronic Advisa MRI Implantable Pulse Generator (IPG) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01110915N/ACompleted
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Advisa MRI™ System Clinical Investigation

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Apr 27, 2010·Updated Apr 30, 2013

In Brief

A clinical study evaluating Medtronic Advisa MRI Implantable Pulse Generator (IPG) and Medtronic CapSureFix MRI™ active fixation MRI lead for Magnetic Resonance Imaging and Cardiac Pacemaker, Artificial. Completed, enrolled 269 participants across 37 sites in 13 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMagnetic Resonance Imaging, Cardiac Pacemaker, Artificial
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Switzerland, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.2 years ago

Interventions

Medtronic Advisa MRI Implantable Pulse Generator (IPG)device

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.

Medtronic CapSureFix MRI™ active fixation MRI leaddevice

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.