MRI Safety for Pacemaker Lead Fracture
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment MRI for pacemaker lead fracture?
Recent studies show that MRI can be safely performed on patients with pacemakers if specific precautions are taken, such as device reprogramming and careful monitoring. Advances in technology have led to the development of 'MR-conditional' devices, which are designed to be safe in the MRI environment, allowing more patients to undergo MRI without significant risks.12345
Is MRI safe for patients with pacemakers?
MRI can be risky for patients with pacemakers due to potential heating of the pacemaker lead and electromagnetic interference. However, some newer pacemaker systems, like the Medtronic EnRhythm MRI SureScan, have been designed and tested for safer use in MRI environments, although they are not yet considered completely 'MRI-safe' or 'MRI-compatible' by the FDA.678910
How is MRI treatment unique for patients with pacemaker lead fractures?
MRI is unique for patients with pacemaker lead fractures because it allows for detailed imaging without surgery, but it requires special 'MR-conditional' pacemakers designed to be safe in the MRI environment. This is different from traditional treatments that might avoid MRI due to safety concerns with standard pacemakers.146711
Research Team
Sandeep Bansal, MD
Principal Investigator
The Heart Group
Eligibility Criteria
This trial is for English or Spanish speaking adults with a broken or unused heart device lead who need an MRI scan. It's not for those unsuitable for MRI due to other reasons, or anyone under 18.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
MRI Scanning
Participants undergo MRI scanning to evaluate safety and efficacy in patients with fractured or abandoned endocardial leads
Follow-up
Participants are monitored for adverse events and symptoms post-MRI scan
Longitudinal Follow-up
Participants may re-enroll for subsequent MRI scans to understand utilization and safety over time
Treatment Details
Interventions
- MRI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lancaster General Hospital
Lead Sponsor