An interventional study of 12-lead ECG monitoring device (MiRTLE Medical) and 3-lead ECG gating system in Atrial Fibrillation, sponsored by Dr. Graham Wright. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Dr. Graham Wright · Not applicable, Interventional, and Other
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 40 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Dr. Graham Wright as lead sponsor.
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Exclusion Criteria:
The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical
Device: 12-lead ECG monitoring device (MiRTLE Medical)
the control group will have MRI with 3-lead ECG gating which is standard of care.
Device: 3-lead ECG gating system
12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;
3-lead ECG gating system is the placebo/standard of care
absolute numbers and percentages
the following patient data will be collected as absolute numbers and percentages in a future Table 1: Age, Sex, Cardiovascular Risk Factors (DM, HTN, Dyslipidemia, smoking, family history of cardiovascular disease), Atrial fibrillation risk factors (CHADS-2 score; CHF, Age \>75, DM, prior stroke/CVA), Prior atrial fibrillation ablation procedures, echocardiographic parameters (LVEF, Left atrial size), MRI parameters (Left ventricular end-diastolic volume, left ventricular end systolic volume, left ventricular stroke volume, LVEF, left atrial volume, right ventricular volumes and ejection fraction.)
Time frame: up to 6 weeks
qualitatively comparison with a standard scale
qualitatively comparison will be done for ECG signal quality and artifact between the 12-lead and 3-lead ECG arms using a standard scale. A 5 point Likert scale will be used with the below scores: 1. indicating 12-lead ecg quality is substantially worse than 3-lead ecg 2. somewhat worse 3. equivalent 4. somewhat better 5. significantly better
Time frame: up to 6 weeks
Plan to share: No
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