Evaluation of MRI-conditional 12-lead ECG

Dr. Graham Wright

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: 12-lead ECG monitoring device (MiRTLE Medical); Device: 3-lead ECG gating system

Study type: Interventional

Funder types: Other

Identifiers

NCT04247685

314-2019

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

12-Lead ECG

Experimental group

Description:

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

Treatment:

Device: 12-lead ECG monitoring device (MiRTLE Medical)

3-lead ECG gating system

Active Comparator group

Description:

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

Treatment:

Device: 3-lead ECG gating system