3T MRI CIED Post-Approval Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/5/2018 |
| Start Date: | April 2016 |
| End Date: | July 2020 |
| Contact: | Medtronic Product Surveillance Registry |
| Email: | rs.productsurveillanceregistry@medtronic.com |
Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
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).
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).
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
We found this trial at
64
sites
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