Evaluation of MRI-conditional 12-lead ECG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 12-lead ECG monitoring device (MiRTLE Medical), 3-lead ECG gating system.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- absolute numbers and percentages [Time frame: up to 6 weeks]
- qualitatively comparison with a standard scale [Time frame: up to 6 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Center — Toronto
Identifiers
NCT: NCT04247685 · 314-2019