Evaluation of MRI-conditional 12-lead ECG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home Telemonitoring In Patients After Myocardial Infarction

NCT04664881

Myocardial Infarction Heart Attack

COMPLETED NA

The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle

NCT00288756

Ventricular Arrythmias

UNKNOWN

Heart Monitoring Device After Acute Myocardium Infarction

NCT03494751

Acute Myocardial Infarction

UNKNOWN NA

Electrocardiographic Mapping and Imaging

NCT01394965

Cardiac Arrhythmia

WITHDRAWN EARLY_PHASE1

Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients

NCT05078125

Premature Ventricular Complex

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The investigators will aim to recruit 2-3 patients per month, with a total of 40 patients over two years. These 40 patients will be assigned into two MRI groups -12-lead ECG gating system as the study group and 3-lead ECG gating system as the control group. The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical, while the control group will have MRI with 3-lead ECG gating which is standard of care. Diagnostic image quality and severity of artifact will be evaluated to compare these two groups.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

12-Lead ECG

The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical

Group Type EXPERIMENTAL

12-lead ECG monitoring device (MiRTLE Medical)

Intervention Type DEVICE

12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;

3-lead ECG gating system

the control group will have MRI with 3-lead ECG gating which is standard of care.

Group Type ACTIVE_COMPARATOR

3-lead ECG gating system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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;

Intervention Type DEVICE

3-lead ECG gating system

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes