Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe)

Saint Luke's Health System

Status: Completed

Conditions: Magnetic Field Exposure

Treatments: Other: Initiate ACLS protocol if lethal arrythmia develops

Study type: Observational

Funder types: Other

Identifiers

NCT03081364

15-335

Details and patient eligibility

About

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

Full 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.

Enrollment: 532 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

532 participants in 1 patient group

Outpatients

Description:

MRI; Critical Care Monitoring, Device Programming

Treatment:

Other: Initiate ACLS protocol if lethal arrythmia develops