3T MRI CIED Post-Approval Study

  • STATUS
    Recruiting
  • End date
    Oct 2, 2021
  • participants needed
    4500
  • sponsor
    Medtronic
Updated on 2 June 2021
Investigator
Micra Registry Manager
Primary Contact
(4.3 mi away) Contact
+142 other location
MRI

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
Condition Arrhythmia, Dysrhythmia, conduction disorders, cardiac arrhythmia, cardiac dysrhythmias, arrhythmias, cardiac arrhythmias, dysrhythmias, abnormal heart rhythms
Clinical Study IdentifierNCT02969395
SponsorMedtronic
Last Modified on2 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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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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