Cardiac Rhythm Disorder
Conditions
Keywords
3T, Magnetic Resonance Imaging (MRI), Implantable Cardioverter Defibrillator (ICD), Implantable Pulse Generator (IPG), Cardiac Resynchronization Therapy (CRT), Cardiac Implantable Electronic Device (CIED)
Brief 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).
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Patients will be followed for approximately 5 years. |
Countries
Belgium, Canada, China, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Portugal, Serbia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed