Implantable Loop Recorder for Atrial Fibrillation (B2AD-Risk AF Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Lawson Health Research Institute

No Placebo Group

Approved in 2 jurisdictions

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. We 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. We 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.

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.

I have had a stroke that was not caused by bleeding.

Exclusion Criteria

I have ongoing or permanent atrial fibrillation.

Treatment Details

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.

3Treatment groups

Active Control

Group I: Known Paroxysmal AFActive Control1 Intervention

Paroxysmal AF known before stroke onset (KAF).

Group II: ECG-AFDASActive Control1 Intervention

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

Group III: PCM-AFDASActive Control1 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: