Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT04247685

Evaluation of MRI-conditional 12-lead ECG

Led by Dr. Graham Wright · Updated on 2025-05-29

40

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of MRI-conditional 12-lead ECG

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age and older
  • Diagnosed with atrial fibrillation
  • Able to provide informed consent
  • Eligible for the Ontario Health Insurance Plan
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Pregnant women
  • Contraindications to cardiac magnetic resonance imaging (CMR)
  • Hemodynamically unstable
  • Presence of a permanent pacemaker or implantable cardioverter defibrillator (ICD)
  • Presence of aneurysm clip or carotid artery vascular clamp
  • Claustrophobia preventing MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

M

Mary Li, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Evaluation of MRI-conditional 12-lead ECG | DecenTrialz