Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038123
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-09-05
Brief Title:
China 3T MRI Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
China CIED 30T MRI Performance Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the China CIED 30T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 30T MRI environment when subjects receive MRI scans ll 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 subjects clinical condition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None