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Advisa MRI Clinical Study

NCT01110915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2013-04-30

Study results available
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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).

Conditions

  • Magnetic Resonance Imaging
  • Cardiac Pacemaker, Artificial

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Advisa MRI Trial Leader · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-03-31
Completion
2013-03-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110915 on ClinicalTrials.gov