Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of MRI-conditional 12-lead ECG
Sponsor: Dr. Graham Wright
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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-01-18
Completion Date
2027-12-31
Last Updated
2025-05-29
Healthy Volunteers
Yes
Conditions
Interventions
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;
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