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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Each year, 7.8 million people worldwide experience an ischemic stroke, often caused by atrial fibrillation (AF). AF is a major contributor to severe, disabling, and deadly strokes. About 20% to 30% of ischemic stroke patients have AF before their stroke. Of the remaining 70% to 80% without known arrhythmias, up to 24% are newly diagnosed with AF after intensive cardiac monitoring, totaling 1.3 to 1.5 million new AF cases detected after stroke globally each year. Oral anticoagulants (OACs) can reduce stroke risk related to AF by 64% and lead to milder strokes with lower disability and mortality. Neurologists use cardiac monitoring to detect AF in stroke patients. This study focuses on patients who have had an ischemic stroke and are newly diagnosed with AF. The goal is to understand how AF progresses over time. The investigators will track changes in AF severity and frequency, monitor biomarkers related to heart health, assess the size and function of the left atrium, and observe new risk factors like hypertension. Patients will be grouped based on their AF diagnosis method: ECG, a portable device recording heart activity for less than 7 days, or one recording for 7 to 30 days. The investigators hypothesize that AF burden will increase, new risk factors will emerge, biomarkers will rise, and the left atrium will worsen over time. Participants will be followed for up to 24 months with regular assessments. The study aims to provide insights into AF progression in stroke patients, potentially improving treatments and prevention 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 data supports the effectiveness of the treatment Implantable Loop Recorder for Atrial Fibrillation?

Implantable loop recorders (ILRs) are effective in providing high-quality heart monitoring data, which helps doctors diagnose and manage atrial fibrillation (AF). They can also detect dangerous heart rhythms and potentially prevent strokes in high-risk patients by identifying AF early. ^{1 2 3 4 5}

Is the implantable loop recorder safe for humans?

The implantable loop recorder (ILR) is generally considered safe for humans, as it is used in various clinical situations to monitor heart rhythms and has been evaluated for safety and accuracy, including the Medtronic Reveal LINQTM model. ^{2 4 6 7 8}

How is the Implantable Loop Recorder treatment different from other treatments for atrial fibrillation?

The Implantable Loop Recorder (ILR) is unique because it continuously monitors the heart's electrical activity over a long period, helping to detect atrial fibrillation (AF) and other arrhythmias that might not be caught during a regular doctor's visit. Unlike other treatments that directly address AF symptoms or prevent strokes, the ILR is primarily a diagnostic tool that helps guide further treatment decisions. ^{1 2 3 4 9}

Research Team

Luciano A Sposato, MD

Principal Investigator

Western University

Eligibility Criteria

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

I have ongoing or permanent atrial fibrillation.

Allergy to iodinated contrast agents

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implantable loop recorders in patients with atrial fibrillation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Implantable loop recorder detection for atrial fibrillation to prevent stroke in high-risk patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse? [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Implantable loop recorder in atrial fibrillation and after catheter ablation]. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Implantable loop recorder allows an etiologic diagnosis in one-third of patients. Results of the Spanish reveal registry. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM. [2019]

8. Norway pubmed.ncbi.nlm.nih.gov

[Implantable loop recorders in evaluation of syncope]. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Implantable loop recorder monitoring in patients with cryptogenic stroke - Detection and treatment of different clinically relevant arrhythmias. [2021]