NCT06038123

China 3T MRI Study

China CIED 3.0T MRI Performance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Tachycardia
• Heart Failure

Interventions

Type	Name	Description
DEVICE	China market released 3.0T Magnetic resonance (MR) conditional CIED systems	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)

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-10-17
• Completion: 2024-10-28
• First posted: 2023-09-14
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

5 sites across 1 country: China