Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT07155135
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices
Sponsor:
Socal Heart
Organization:
Study Overview
Official Title:
Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices
Status:
COMPLETED
Status Verified Date:
2025-08
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:
MRIMLD
Brief Summary:
This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.
Detailed Description:
Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.
Study Oversight
Has Oversight DMC:
False
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?: