Evaluating a new ECG system for MRI scans
Evaluation of MRI-conditional 12-lead ECG
This study tests a new ECG system designed for MRI scans to see if it can better monitor heart problems in patients with atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04247685 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel MRI-conditional 12-lead ECG monitoring system developed by MiRTLE Medical, designed to improve the detection of arrhythmias and ischemia during cardiac MRI scans. Currently, standard care uses a 3-lead ECG system, which may not adequately monitor patients with atrial fibrillation undergoing MRI. The new system aims to reduce interference from MRI's magnetic fields and radio frequency pulses, potentially enhancing patient safety and diagnostic accuracy. The study will assess the efficacy of this advanced ECG system in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have atrial fibrillation and are eligible for MRI scans.
Not a fit: Patients who may not benefit include those who are pregnant, hemodynamically unstable, or have contraindications for cardiac MRI.
Why it matters
Potential benefit: If successful, this new ECG system could significantly improve the safety and diagnostic capabilities during MRI scans for patients with atrial fibrillation.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mary Li, MSc
- Email: mary.li@sunnybrook.ca
- Phone: 4164806100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.