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Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03081364
Acronym
PROMeNADe
Enrollment
532
Registered
2017-03-16
Start date
2015-09-30
Completion date
2022-09-30
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Field Exposure

Keywords

Cardiac Implanted Device

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.

Interventions

OTHERInitiate ACLS protocol if lethal arrythmia develops

Cardiac Rhythm Management

Sponsors

Saint Luke's Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Device Function3 yearsChange in lead impedance or sensing
Change in Thresholds of Pacing Lead3 yearsMeasured in mA
Dysrhythmias Noted During Scan3 yearsChange in heart rhythm
Oxygen Saturation3 yearsPercentage of change or no change
Change in heart rate3 yearsMeasured as beats per minute on single-lead heart monitor.
Patient Comments3 yearsReal-time patient report via intercom during scan of chest symptoms such as burning or aching
Interference Between the Implanted Cardiac Electronic Device and MRI3 yearsMeasure any change in device battery voltage
Change in blood pressure3 yearsMonitored with automatic blood pressure cuff

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026