Evaluation of MRI-conditional 12-lead ECG

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    40
  • sponsor
    Dr. Graham Wright
Updated on 27 March 2021

Summary

With MRI's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for MRI exams. Currently, 3-lead ECG gating systems are utilized during cardiac MRI scanning as standard of care. However, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during MRI scanning. Morevoer, MRI associated magnetic fields and radio frequency pulses can produce interference in the ECG signal that leads to non-diagnostic ECG signals. MiRTLE Medical, a Massachusetts-based medical device company, has developed a high-fidelity, MRI-conditional 12-lead ECG monitoring system. This 12-lead ECG system is a first of its kind that addresses the MRI-induced interference and safety issues. This study is to evaluate the efficacy of this 12-lead ECG system in the clinical setting. The investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment 12-lead ECG monitoring device (MiRTLE Medical), 3-lead ECG gating system
Clinical Study IdentifierNCT04247685
SponsorDr. Graham Wright
Last Modified on27 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age and older
Atrial fibrillation
Provision of informed consent
Eligible for the Ontario Health Insurance Plan

Exclusion Criteria

Failure to provide informed consent
Pregnant women
CMR contra-indicated
Hemodynamically unstable
Permanent pacemaker/ICD
Aneurysm clip/carotid artery vascular clamp
Claustrophobic
Clear my responses

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