Atrial FibrillationNCT04247685
Evaluation of MRI-conditional 12-lead ECG
A study testing 12-lead ECG monitoring device (MiRTLE Medical) and 3-lead ECG gating system in people with Atrial Fibrillation, run by Dr. Graham Wright at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 12-lead ECG monitoring device (MiRTLE Medical) and 3-lead ECG gating system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Atrial fibrillation
- Provision of informed consent
- Eligible for the Ontario Health Insurance Plan
Who cannot join
- Failure to provide informed consent
- Pregnant women
- CMR contra-indicated
- Hemodynamically unstable
- Permanent pacemaker/ICD
- Aneurysm clip/carotid artery vascular clamp
- Claustrophobic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Mary Li, 4164806100 ext. 89664, mary.li@sunnybrook.ca
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- 12-lead ECG monitoring device (MiRTLE Medical), 3-lead ECG gating system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-lead ECG monitoring device (MiRTLE Medical)Device
12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;
3-lead ECG gating systemDevice
3-lead ECG gating system is the placebo/standard of care
| Study group | Role | What they receive |
|---|---|---|
| 12-Lead ECG | Experimental | The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical Receives: Device: 12-lead ECG monitoring device (MiRTLE Medical) |
| 3-lead ECG gating system | Active comparator | the control group will have MRI with 3-lead ECG gating which is standard of care. Receives: Device: 3-lead ECG gating system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: up to 6 weeks
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
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start18 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Graham Wright
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Graham Wright, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247685
- Sponsor's protocol ID
- 314-2019
- Status last verified
- May 2025
- First submitted
- 28 Oct 2019
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MRI-conditional 12-lead ECG
- ClinicalTrials.gov ID
- NCT04247685
- Acronym / sponsor ID
- 314-2019
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Graham WrightUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 12-Lead ECG | Experimental | Device: 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 | Active comparator | Device: 3-lead ECG gating systemthe control group will have MRI with 3-lead ECG gating which is standard of care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- Atrial fibrillation
- Provision of informed consent
- Eligible for the Ontario Health Insurance Plan
Key exclusion criteria (7 listed)
- Failure to provide informed consent
- Pregnant women
- CMR contra-indicated
- Hemodynamically unstable
- Permanent pacemaker/ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 12-Lead ECG |
| 3-lead ECG gating system3-lead ECG gating system is the placebo/standard of care | Device | 3-lead ECG gating system |
Primary outcome
absolute numbers and percentages
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-lead ECG monitoring device (MiRTLE Medical) and 3-lead ECG gating system in people with Atrial Fibrillation, run by Dr. Graham Wright at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Li, MSc (4164806100 ext. 89664, mary.li@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute numbers and percentages (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.