Trials / Completed
CompletedNCT02969395
3T MRI CIED Post-Approval Study
Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 41 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2021-10-15
- Completion
- 2021-10-15
- First posted
- 2016-11-21
- Last updated
- 2022-08-22
Locations
204 sites across 22 countries: United States, Belgium, Canada, China, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Portugal, Serbia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02969395. Inclusion in this directory is not an endorsement.