Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Completed

• Conditions: Magnetic Field Exposure

• Registration Number: NCT03081364
• Lead Sponsor: Saint Luke's Health System

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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