No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
4,000 (estimated)
Sponsor
Hamilton Health Sciences Corporation · Other
Who this trial is looking for
This trial is looking for people with atrial fibrillation who are at high risk of stroke, even while taking blood thinners. Participants will undergo a procedure to block a specific part of the heart to see if it helps prevent strokes.
Are You a Good Fit for This Trial?
Must be takingOral anticoagulants
Must not be takingDirect thrombin inhibitors
Rules you outShort life expectancy
You may be able to join if
I have persistent or permanent atrial fibrillation
I have paroxysmal atrial fibrillation and a history of stroke
I have a CHA2DS2-VASc score of 4 or higher
I have been taking blood thinners for at least 90 days
I do not plan to stop taking blood thinners during the trial
You may not be able to join if
I am under 18 years old
I currently have a blood clot in my heart
I have had a procedure to close or remove the left atrial appendage
I have had a procedure to close a hole in my heart
I have had atrial fibrillation treatment and still have the condition after 30 days
I plan to have atrial fibrillation treatment in the next 90 days
I am taking direct thrombin inhibitors
I cannot or will not give informed consent
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stand…
Inclusion Criteria:
1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.
Exclusion Criteria:
1. Age \< 18 years
2. Current left atrial appendage thrombus
3. Prior left atrial appendage occlusion or removal (surgical or percutaneous)
4. Prior percutaneous atrial septal defect or patent foramen ovale closure
5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
6. Planned atrial fibrillation ablation within 90 days of enrollment
7. Individuals being treated with direct thrombin inhibitors
8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
9. Anticipated life-expectancy of \< 2 years
10. Patient unable or willing to give informed consent
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