MRI-Compatible 12-Lead ECG for Heart Monitoring

Overseen By Mary Li, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Graham Wright

Disqualifiers: Pregnancy, Pacemaker, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of 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.

Eligibility Criteria

This trial is for adults over 18 with atrial fibrillation who have health insurance coverage through the Ontario Health Insurance Plan. It's not suitable for those with certain metal implants, claustrophobia, pregnant women, people unstable in their blood circulation or those with a permanent pacemaker or ICD.

Inclusion Criteria

Eligible for the Ontario Health Insurance Plan

Provision of informed consent

I have been diagnosed with atrial fibrillation.

Exclusion Criteria

You are afraid of being in small or enclosed spaces.

You have a permanent pacemaker or ICD (implantable cardioverter defibrillator) in your body.

I cannot undergo CMR due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI with either the 12-lead ECG monitoring device or the standard 3-lead ECG gating system

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3-lead ECG gating system
• MRI-conditional 12-lead ECG monitoring system (MiRTLE Medical)

Trial Overview The study tests a new MRI-compatible 12-lead ECG monitoring device against the standard 3-lead system during cardiac MRI scans. The goal is to see if the new device can better detect heart issues without being affected by MRI interference.

Participant Groups

Group I: 12-Lead ECG Experimental Treatment 1 Intervention

The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical

Group II: 3-lead ECG gating system Active Control 1 Intervention

the control group will have MRI with 3-lead ECG gating which is standard of care.

Who Is Running the Clinical Trial?

Dr. Graham Wright

Lead Sponsor

Trials

1

Recruited

40+