Status:
NOT_YET_RECRUITING
The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups
Lead Sponsor:
The Scripps Research Institute
Conditions:
Pacemakers
MRI Imaging
Eligibility:
All Genders
18+ years
Brief Summary
SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for cl...
Detailed Description
1\. INTRODUCTION 1.1 Specific aims The specific aims of the MagnaSafe-2 registry are to document the risks of magnetic resonance imaging (MRI) at a scanner strength of 3-tesla for patients with a non-...
Eligibility Criteria
Inclusion
- Patients will be included in the registry if they fulfill all the following criteria:
- Age of 18 years or older
- Able to provide informed consent for entry in the research registry
- Have a CIED from any manufacturer implanted after 2001
- Have cardiac leads from any manufacturer without an implant date limitation
- Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology
- The patient is scheduled for that imaging procedure
- MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol
- In addition, groups within the protocol require that an enrolled patient will have:
- An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.
- A "mixed-vendor" or same vendor "mixed-component" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.
- A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.
Exclusion
- Patients will not be included in the registry if they fulfill any of the following criteria:
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- A generator battery at the elective replacement indicator (ERI)
- Renal insufficiency (GFR \<45 cc/min)
- In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed.
- Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils)
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Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07189728
Start Date
January 1 2026
End Date
January 1 2031
Last Update
September 24 2025
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