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Completed

NCT Number: NCT03081364

Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

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

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Key information

Conditions

Magnetic Field Exposure

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initiate ACLS protocol if lethal arrythmia develops

Other

Cardiac Rhythm Management

Primary outcomes

  1. Change in Device Function

    Time frame: 3 years

    Change in lead impedance or sensing

  2. Change in Thresholds of Pacing Lead

    Time frame: 3 years

    Measured in mA

  3. Dysrhythmias Noted During Scan

    Time frame: 3 years

    Change in heart rhythm

  4. Oxygen Saturation

    Time frame: 3 years

    Percentage of change or no change

  5. Change in heart rate

    Time frame: 3 years

    Measured as beats per minute on single-lead heart monitor.

  6. Patient Comments

    Time frame: 3 years

    Real-time patient report via intercom during scan of chest symptoms such as burning or aching

  7. Interference Between the Implanted Cardiac Electronic Device and MRI

    Time frame: 3 years

    Measure any change in device battery voltage

  8. Change in blood pressure

    Time frame: 3 years

    Monitored with automatic blood pressure cuff

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Registry information

Acronym: PROMeNADe

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2017
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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