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Evaluation of MRI-conditional 12-lead ECG

NCT04247685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

12-lead ECG monitoring device (MiRTLE Medical)

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

DEVICE

3-lead ECG gating system

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

Sponsors & Collaborators

  • Dr. Graham Wright

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247685 on ClinicalTrials.gov