Last updated on May 2019

3T MRI CIED Post-Approval Study

Brief description of study

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 Identifier: NCT02969395

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Medtronic Product Surveillance Registry

Colorado Springs, CO United States
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Medtronic Product Surveillance Registry

Saint Louis Park, MN United States
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Medtronic Product Surveillance Registry

Charlottesville, VA United States
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Recruitment Status: Open

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