An observational study in Cardiac Rhythm Disorder, sponsored by Medtronic. Completed at 204 sites in 22 countries. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Medtronic · Observational
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).
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 41 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients intended to be implanted or are within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Exclusion Criteria:
The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure.
Time frame: Patients will be followed for approximately 5 years.
Showing the first 100 of 204 sites across 22 countries.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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