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RECRUITINGINTERVENTIONAL

Evaluation of MRI-conditional 12-lead ECG

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 18 years of age and older - Atrial fibrillation - Provision of willing to sign a consent form - Eligible for the Ontario Health Insurance Plan Who Should NOT Join This Trial: - Failure to provide willing to sign a consent form - Pregnant women - CMR contra-indicated - Hemodynamically unstable - Permanent pacemaker/ICD - Aneurysm clip/carotid artery vascular clamp - Claustrophobic Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 18 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

Treatments Being Tested

DEVICE

12-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;

DEVICE

3-lead ECG gating system

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

Locations (1)

Sunnybrook Health Sciences Center
Toronto, Ontario, Canada