Adverse Events of MRI With Abandoned Leads

Lancaster General Hospital

Status: Terminated

Conditions: Pacemaker Electrode Lead Fracture; ICD

Treatments: Procedure: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04478773

2020-43

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Experimental

Experimental group

Description:

Patient will receive MRI

Treatment:

Procedure: MRI