RecruitingNot ApplicableNCT04247685

Evaluation of MRI-conditional 12-lead ECG


Sponsor

Dr. Graham Wright

Enrollment

40 participants

Start Date

Jan 18, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

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

Exclusion Criteria7

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

Interventions

DEVICE12-lead ECG monitoring device (MiRTLE Medical)

12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;

DEVICE3-lead ECG gating system

3-lead ECG gating system is the placebo/standard of care


Locations(1)

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

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NCT04247685


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