Adverse Events of MRI With Abandoned Leads

Stopped early · Not applicable

Conditions studied: Pacemaker Electrode Lead Fracture, ICD

In brief

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.

Key facts

Study ID

NCT04478773

Run by

Lancaster General Hospital

People needed

18

Starts

2020-12-02

Expected to finish

2023-06-30

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients implanted with or without an ICD or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for MR imaging
• Patients are English or Spanish speaking and able to review and sign the consent

You may not qualify if…

• Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.
• Patients less than 18 years of age

Where it is running

• Lancaster General Health — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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