China 3T MRI Study
NCT06038123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-01-14
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
- 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)
Sponsors & Collaborators
-
Medtronic Cardiac Rhythm and Heart Failure
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-28
- Primary Completion
- 2024-10-17
- Completion
- 2024-10-28
Countries
- China
Study Locations
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