Evaluation of MRI-conditional 12-lead ECG

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: 12-lead ECG monitoring device (MiRTLE Medical); Device: 3-lead ECG gating system

• Registration Number: NCT04247685
• Lead Sponsor: Dr. Graham Wright

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2021-01-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-Lead ECG	12-lead ECG monitoring device (MiRTLE Medical)	The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical
3-lead ECG gating system	3-lead ECG gating system	the control group will have MRI with 3-lead ECG gating which is standard of care.

Primary Outcome Measures

Name	Time	Method
absolute numbers and percentages	up to 6 weeks	the following patient data will be collected as absolute numbers and percentages in a future Table 1: Age, Sex, Cardiovascular Risk Factors (DM, HTN, Dyslipidemia, smoking, family history of cardiovascular disease), Atrial fibrillation risk factors (CHADS-2 score; CHF, Age \>75, DM, prior stroke/CVA), Prior atrial fibrillation ablation procedures, echocardiographic parameters (LVEF, Left atrial size), MRI parameters (Left ventricular end-diastolic volume, left ventricular end systolic volume, left ventricular stroke volume, LVEF, left atrial volume, right ventricular volumes and ejection fraction.)
qualitatively comparison with a standard scale	up to 6 weeks	qualitatively comparison will be done for ECG signal quality and artifact between the 12-lead and 3-lead ECG arms using a standard scale. A 5 point Likert scale will be used with the below scores: 1. indicating 12-lead ecg quality is substantially worse than 3-lead ecg; 2. somewhat worse; 3. equivalent; 4. somewhat better; 5. significantly better

Trial Locations

Locations (1)

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontario, Canada