Adverse Events of MRI With Abandoned Leads

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads

Conditions
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Pacemaker Electrode Lead Fracture, ICD

Intervention / Treatment
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* Procedure: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patient will receive MRI | Procedure: MRI<br>* MRI with or without contrast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads | Incidence of symptoms and adverse events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads. The following measures will be collected twice during the MRI scan and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Proportion/percentage of participants with: Pulling in pocket Chest pain Burning in pocket Palpitations Shortness of breath Other Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with: Atrial fibrillation Ventricular arrhythmias Frequent premature ventricular contractions with hemodynamic instability Symptomatic bradycardia with heart rate less than 40 beats per minute | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understand longitudinal utilization and safety of subsequent MRIs | The second component of the study allows subjects to re-enroll for subsequent MRI scans as ordered by their physician to understand utilization and safety. The following measures will be collected and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider : Patient Reported Symptoms - collected twice during the MRI scan. Number of participants with a subsequent MRI that experience: pulling in pocket chest pain burning in pocket palpitations shortness of breath Other Adverse Events - collected via device monitor after MRI scan. Number of participants with: atrial fibrillation ventricular arrhythmias frequent premature ventricular contractions with hemodynamic instability symptomatic bradycardia with heart rate less than 40 beats per minute | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abandoned lead, fractured lead