Implantable Loop Recorder for Atrial Fibrillation

(B2AD-Risk AF Trial)

Overseen By Jennifer Moussa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Must be taking: Oral anticoagulants

Disqualifiers: Permanent AF, Iodine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the progression of atrial fibrillation (AF) in individuals who have experienced a stroke. AF, an irregular heartbeat, can lead to strokes. The study uses an implantable loop recorder, a small device placed under the skin, to continuously monitor heart rhythms over time. Researchers will observe changes in heart rhythm, heart size, and other health markers. The trial seeks participants who have recently had a specific type of stroke and have been newly diagnosed with AF through tests like an ECG or a 14-day heart monitor. This research could lead to improved methods for treating and preventing strokes caused by AF. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future stroke prevention and treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves monitoring atrial fibrillation, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

What prior data suggests that the Implantable Loop Recorder is safe for monitoring atrial fibrillation?

Research has shown that implantable loop recorders (ILRs) are generally safe for people. Studies have found ILRs effective in detecting serious heart rhythm problems in many patients, allowing doctors to identify issues without harming the patient. Other reports also highlight the safety of these devices, noting their effectiveness in various situations, even during MRIs, provided the healthcare team is informed.

Additionally, early results from another study indicated that ILRs are safe to insert and effectively transmit data. This data aids in identifying heart rhythm issues like atrial flutter, which resembles atrial fibrillation. Overall, ILRs are well-tolerated and have a strong safety record, making them a reliable choice for monitoring heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Implantable Loop Recorders (ILRs) for monitoring atrial fibrillation (AF) because these devices offer continuous, long-term heart rhythm tracking, unlike traditional methods like intermittent ECGs or Holter monitors. This constant monitoring increases the chances of detecting sporadic AF episodes that might be missed with standard methods. Additionally, ILRs are minimally invasive and can be implanted under the skin, providing a more convenient and comfortable option for patients compared to frequent hospital visits for monitoring. By potentially catching AF earlier, ILRs could lead to more timely interventions and better outcomes for patients.

What evidence suggests that the Implantable Loop Recorder is effective for monitoring atrial fibrillation?

Research has shown that a small device called an Implantable Loop Recorder (ILR) effectively detects atrial fibrillation (AF) in individuals who have experienced a stroke. In this trial, participants will be divided into groups based on how AF is detected: those with known paroxysmal AF before stroke onset, those with AF found on an admission or Emergency Department ECG, and those with AF detected through 14-day Holter monitoring. Studies have found that ILRs detect AF in about 25.5% of patients with unexplained strokes, outperforming traditional methods. The ILR continuously monitors heart rhythms, identifying AF episodes that shorter checks might miss. Early detection of AF allows doctors to initiate treatments like blood thinners, reducing the risk of another stroke. Overall, ILRs enhance AF detection, leading to improved stroke prevention strategies. ^{2 5 6 7 8}

Who Is on the Research Team?

Luciano A Sposato, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for patients who've had an ischemic stroke and are newly diagnosed with atrial fibrillation (AF). It's important that they haven't been using long-term heart rhythm monitoring devices before. The study aims to track the progression of AF over time, looking at changes in its severity and frequency, as well as other heart health indicators.

Inclusion Criteria

I had episodes of irregular heartbeat before my stroke.

Paroxysmal AF found on an admission or Emergency Department ECG (ECG-AFDAS)

Paroxysmal AF found on 14-day Holter monitoring (PCM-AFDAS)

Exclusion Criteria

Patients not willing to consent

Allergy to iodinated contrast agents

I have ongoing or permanent atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including echocardiography, plasma biomarkers, and cardiac CT scans to evaluate heart health

1 month

1 visit (in-person)

Monitoring and Follow-up

Regular monitoring of AF burden, biomarkers, and heart health over time

24 months

Regular assessments throughout the study period

Final Assessment

Final evaluation including echocardiography, plasma biomarkers, and cardiac CT scans to assess changes in heart health

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Loop Recorder

Trial Overview The intervention being studied is the use of an Implantable Loop Recorder to monitor heart activity in stroke patients with new AF diagnoses. The device will help researchers understand how AF burden evolves by tracking it continuously over a period of up to 24 months.

How Is the Trial Designed?

Group I: Known Paroxysmal AF Active Control 1 Intervention

Paroxysmal AF known before stroke onset (KAF).

Group II: ECG-AFDAS Active Control 1 Intervention

Paroxysmal AF found on an admission or Emergency Department ECG (ECG-AFDAS)

Group III: PCM-AFDAS Active Control 1 Intervention

Paroxysmal AF found on 14-day Holter monitoring (PCM-AFDAS)

Implantable Loop Recorder is already approved in European Union, United States for the following indications:

Approved in European Union as LUX-Dx for:

• Atrial fibrillation
• Cryptogenic stroke
• Syncope

Approved in United States as LUX-Dx for:

• Cardiac arrhythmias
• Atrial fibrillation
• Cryptogenic stroke
• Syncope

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Published Research Related to This Trial

In a study of 181 patients with unexplained syncope, presyncope, or palpitations, the implantable loop recorder (ILR) was able to provide a diagnostic result in 54.1% of cases, confirming its value in identifying cardiac arrhythmias.

The average time to a diagnostic event was about 11 months, and the ILR was particularly effective for patients with syncope or presyncope, suggesting it should be considered early in the evaluation process for these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations. Radovanović, NN., Pavlović, SU., Kirćanski, B., et al.[2021]

The Medtronic Reveal LINQTM implantable loop recorder (ILR) was successfully used in 154 patients, allowing for remote monitoring and leading to earlier diagnosis of serious arrhythmias in 64% of cases during an average follow-up of 12.1 months.

While the device was generally safe, with only one case of skin erosion and no infections, there were notable issues with false bradycardia detection in 29% of patients due to undersensing, highlighting a technical challenge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM. Maines, M., Zorzi, A., Tomasi, G., et al.[2019]

The BioMonitor 2-AF, an implantable loop recorder, demonstrated high P-wave visibility (94.4%) and effective remote monitoring with 100% successful automatic transmissions, indicating its reliability for continuous cardiac monitoring.

No complications related to the ILR were reported, and while some misclassification of episodes occurred in 15.8% of patients, the overall safety and effectiveness of the device were confirmed in this first-in-human study involving 19 patients over a 6-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse? Lacour, P., Dang, PL., Huemer, M., et al.[2019]

In a study involving 743 patients who received implantable loop recorders (ILRs) for diagnosing arrhythmias, recurrent syncope was the most common reason for implantation, accounting for 76.4% of cases.

The ILR successfully provided a final diagnosis for about one-third of patients, with syncope due to bradyarrhythmia being the most frequent diagnosis, indicating its effectiveness in real-world clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable loop recorder allows an etiologic diagnosis in one-third of patients. Results of the Spanish reveal registry. Lacunza-Ruiz, FJ., Moya-Mitjans, A., Martínez-Alday, J., et al.[2019]

Implantable loop recorders (ILRs) are considered the gold standard for detecting atrial fibrillation (AF), offering superior diagnostic capabilities compared to other monitoring methods.

ILRs not only help in diagnosing AF but are also useful for monitoring patients after AF ablation, although more research is needed to clarify how the detection of AF via ILRs should influence treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable loop recorders in patients with atrial fibrillation. Sharma, AN., McIntyre, WF., Nguyen, ST., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.035956

Global Results of Implantable Loop Recorder for Detection ... Meta‐analyses on poststroke cardiac rhythm monitoring have shown higher rates of AF detection and oral anticoagulation (OAC) initiation in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3662328/

Incidence of atrial fibrillation detected by implantable loop ... In patients with unexplained stroke, AF was detected by ILR in 25.5%. Predictors of AF were identified, which may help to target investigations.

3. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/24543-loop-recorder

Implantable Loop Recorder (ILR) It monitors your heart rate and rhythm and records anything that's abnormal. Most stay implanted for up to three years, but it may come out sooner if your ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2021/08/28/01/38/LOOP

Atrial Fibrillation Detected by Continuous ECG Monitoring ... The LOOP trial showed that continuous monitoring for AF with an ILR (followed by treatment with OAC if AF was detected) was not superior to usual care in ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2780491

Effect of Implantable vs Prolonged External ... Implantable electrocardiographic monitoring for 12 months resulted in the detection of more patients with atrial fibrillation compared with prolonged external ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5129687/

Efficacy And Safety Of Implantable Loop Recorder ILR proved to be safe and efficient. It has enabled the identification or exclusion of serious rhythm disturbances in more than half of patients.

7. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/lux-dx-icm/Clinical-Cardiology-2022-Preliminary-results-LUXDx.pdf

Preliminary results from the LUX‐Dx insertable cardiac ... Interim results from LUX‐Dx PERFORM study demonstrate the safety of insertion, high data transmission rates, the ability to detect atrial flutter, and the ...

8. mayoclinic.org mayoclinic.org/tests-procedures/implantable-loop-recorder/about/pac-20579708

Implantable loop recorder: A heart monitoring device An implantable loop recorder is considered safe for use during magnetic resonance imaging (MRI). But always tell your healthcare team that you ...