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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

I have been diagnosed with atrial fibrillation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

absolute numbers and percentages

qualitatively comparison with a standard scale

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.

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this experiment?

"Affirmative. The data hosted on clinicaltrials.gov shows that recruitment for this medical trial has been ongoing since January 18th 2021, with the most recent update being October 31st 2022. 40 individuals are needed to come from one specific site."

Answered by AI

Is enrollment still open for this research project?

"The clinical trial, whose inception was announced on January 18th 2021, is still recruiting patients as indicated by the most current update posted on October 31st 2022."

Answered by AI