3T MRI CIED Post-Approval Study

  • STATUS
    Recruiting
  • End date
    Oct 17, 2021
  • participants needed
    4500
  • sponsor
    Medtronic
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Updated on 17 December 2020
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Summary

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).

Details
Clinical Study IdentifierNCT02969395
SponsorMedtronic
Last Modified on17 December 2020

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Eligibility

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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 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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