3T MRI CIED Post-Approval Study
Completed
- Conditions
- Cardiac Rhythm Disorder
- Registration Number
- NCT02969395
- Lead Sponsor
- Medtronic
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method