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NCT04247685Recruiting

Evaluation of MRI-conditional 12-lead ECG

Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
28 Oct 2019
Start date
18 Jan 2021
Primary completion date
31 Dec 2026
Lead sponsor
Dr. Graham Wright
NCT number
NCT04247685

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 18 Jan 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to provide informed consent

Other

  • Pregnant women
  • CMR contra-indicated
  • Hemodynamically unstable
  • Permanent pacemaker/ICD
  • Aneurysm clip/carotid artery vascular clamp
  • Claustrophobic

Who the study is looking for

  • 18 years of age and older
  • Atrial fibrillation
  • Provision of informed consent
  • Eligible for the Ontario Health Insurance Plan

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sunnybrook Health Sciences Center
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.