At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
China CIED 3.0T MRI Performance Study
In Brief
A clinical study evaluating China market released 3.0T Magnetic resonance (MR) conditional CIED systems for Bradycardia and 2 related conditions. Completed, enrolled 64 participants across 5 sites.
Detailed Summary
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. All subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.
Study Details
Timeline
Interventions
To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body)