NCT03081364

Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 532 (actual)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Magnetic Field Exposure

Interventions

Type	Name	Description
OTHER	Initiate ACLS protocol if lethal arrythmia develops	Cardiac Rhythm Management

Timeline

• Start date: 2015-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-03-16
• Last updated: 2023-06-12