3T MRI CIED Post-Approval Study

  • End date
    Oct 17, 2021
  • participants needed
  • sponsor
Updated on 17 December 2020


The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Clinical Study IdentifierNCT02969395
Last Modified on17 December 2020

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Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Dysrhythmia or Arrhythmia?
Do you have any of these conditions: abnormal heart rhythms or dysrhythmias or cardiac dysrhythmias or Dysrhythmia or arrhythmias or conduction disorders or cardiac arrhythmias or Arrhyth...?
Do you have any of these conditions: cardiac arrhythmias or cardiac dysrhythmias or Arrhythmia or arrhythmias or cardiac arrhythmia or dysrhythmias or conduction disorders or abnormal hea...?
Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system

Exclusion Criteria

Subject who is, or will be inaccessible for follow-up at a study site
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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