Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Study Overview
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Brief Summary
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The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)

Detailed Description
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At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.

Official Title
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Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Conditions
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Magnetic Field Exposure

Intervention / Treatment
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* Other: Initiate ACLS protocol if lethal arrythmia develops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anyone with a cardiac device Exclusion Criteria: Anyone who cannot consent for themselves or who don't have a durable power of attorney

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients<br>MRI; Critical Care Monitoring, Device Programming | Other: Initiate ACLS protocol if lethal arrythmia develops<br>* Cardiac Rhythm Management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Device Function | Change in lead impedance or sensing | 3 years | 
| Change in Thresholds of Pacing Lead | Measured in mA | 3 years | 
| Dysrhythmias Noted During Scan | Change in heart rhythm | 3 years | 
| Oxygen Saturation | Percentage of change or no change | 3 years | 
| Change in heart rate | Measured as beats per minute on single-lead heart monitor. | 3 years | 
| Patient Comments | Real-time patient report via intercom during scan of chest symptoms such as burning or aching | 3 years | 
| Interference Between the Implanted Cardiac Electronic Device and MRI | Measure any change in device battery voltage | 3 years | 
| Change in blood pressure | Monitored with automatic blood pressure cuff | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Implanted Device