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NCT Number: NCT04247685

Evaluation of MRI-conditional 12-lead ECG

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Mary Li

CONTACT

[email protected]

4164806100 ext. 89664

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-lead ECG monitoring device (MiRTLE Medical)

Device

12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;

3-lead ECG gating system

Device

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

Primary outcomes

  1. absolute numbers and percentages

    Time frame: up to 6 weeks

    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.)

  2. qualitatively comparison with a standard scale

    Time frame: up to 6 weeks

    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:

    • indicating 12-lead ecg quality is substantially worse than 3-lead ecg
    • somewhat worse
    • equivalent
    • somewhat better
    • significantly better

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Li, MSc

CONTACT

[email protected]

4164806100 ext. 89664

Sponsors and collaborators

Lead sponsor

Dr. Graham Wright

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2020
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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