Evaluation of MRI-conditional 12-lead ECG

Atrial Fibrillation Clinical Trial

Official title:

Evaluation of MRI-conditional 12-lead ECG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247685
• Other study ID #: 314-2019
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Mary Li, MSc
• Phone: 4164806100
• Email: mary.li[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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;
• 3-lead ECG gating system
3-lead ECG gating system is the placebo/standard of care

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Graham Wright

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute numbers and percentages	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.)	up to 6 weeks
Primary	qualitatively comparison with a standard scale	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: indicating 12-lead ecg quality is substantially worse than 3-lead ecg; somewhat worse; equivalent; somewhat better; significantly better	up to 6 weeks