Clinical Trials Detalhe
3T MRI CIED Post-Approval Study
General Information
Gender
ALL
Age
N/A
Phase
N/A
Study Type
OBSERVATIONAL
Location
Creixomil, Portugal
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT02969395Summary
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).
Conditions
Cardiac Rhythm Disorder
Eligibility
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