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MRI-Compatible 12-Lead ECG for Heart Monitoring

N/A
Recruiting
Research Sponsored by Dr. Graham Wright
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age and older
Diagnosis of atrial fibrillation
Must not have
Contraindication for CMR
Hemodynamically unstable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new 12-lead ECG system that is MRI-conditional and addresses the MRI-induced interference and safety issues.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive monitoring during an MRI scan, side effects are minimal but may include discomfort from lying still and anxiety within the confined space of an MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo CMR due to health reasons.
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My blood pressure is not stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
absolute numbers and percentages
qualitatively comparison with a standard scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 12-Lead ECGExperimental Treatment1 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 systemActive Control1 Intervention
the control group will have MRI with 3-lead ECG gating which is standard of care.

Find a Location

Who is running the clinical trial?

Dr. Graham WrightLead Sponsor

Media Library

MRI-conditional 12-lead ECG monitoring system (MiRTLE Medical) Clinical Trial Eligibility Overview. Trial Name: NCT04247685 — N/A
Atrial Fibrillation Research Study Groups: 12-Lead ECG, 3-lead ECG gating system
Atrial Fibrillation Clinical Trial 2023: MRI-conditional 12-lead ECG monitoring system (MiRTLE Medical) Highlights & Side Effects. Trial Name: NCT04247685 — N/A
MRI-conditional 12-lead ECG monitoring system (MiRTLE Medical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04247685 — N/A
~8 spots leftby Nov 2025
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