3T MRI CIED Post-Approval Study

Cardiac Rhythm Disorder Clinical Trial

Official title:
Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02969395
Study type	Observational [Patient Registry]
Source	Medtronic
Contact
Status	Completed
Phase
Start date	April 2016
Completion date	October 15, 2021

View Details

See also
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