Evaluation of MRI-conditional 12-lead ECG

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

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

🚫 You may not be able to join if…

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

Where this trial is running

• Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

Who to contact

Mary Li, MSc · 4164806100 · mary.li@sunnybrook.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04247685.