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Procedure

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

N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Paroxysmal AF known before stroke onset (KAF)
Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke
Must not have
Permanent or persistent AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
No Placebo-Only Group

Summary

"This trial focuses on patients who have had a type of stroke caused by an irregular heartbeat called atrial fibrillation (AF). The study aims to track how AF progresses over time in these patients by monitoring

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not detailed here, generally implantable loop recorders may cause discomfort or infection at the implant site, bleeding, bruising, or rarely more serious complications related to the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had episodes of irregular heartbeat before my stroke.
Select...
I have had a stroke that was not caused by bleeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have ongoing or permanent atrial fibrillation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression of AF burden
Total AF burden
Secondary study objectives
Left atrial size
Progression in the number of diagnosed risk factors
Progression of biomarkers
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,316 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
9,314 Patients Enrolled for Atrial Fibrillation
~16 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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