WATCHMAN Device for Atrial Fibrillation
(LAAOS-4 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to continue taking their current oral anticoagulant medications (like Vitamin K agonists or factor Xa inhibitors) for the duration of the study.
What data supports the effectiveness of the WATCHMAN device treatment for atrial fibrillation?
The WATCHMAN device is designed to reduce the risk of stroke in patients with atrial fibrillation. The PREVAIL trial showed that the benefits of the WATCHMAN device outweigh the risks for patients who meet specific criteria, despite some concerns about ischemic strokes. The newer WATCHMAN FLX device has shown good procedural success and safety in small studies, with improvements in design to enhance performance and safety.12345
Is the WATCHMAN device safe for humans?
The WATCHMAN device has been studied for safety, with an overall adverse event rate of 7.3% and a mortality rate of 0.4% in a large study. Most issues occurred during or shortly after the procedure, but some serious events like strokes and device movement happened more than a month later. The newer WATCHMAN FLX device is designed to improve safety and has shown good results in smaller studies.13467
How does the WATCHMAN device treatment for atrial fibrillation differ from other treatments?
The WATCHMAN device is a unique treatment for atrial fibrillation as it is a small implant placed in the heart to prevent strokes by blocking the left atrial appendage, where blood clots often form. Unlike traditional blood-thinning medications, it offers an alternative for patients who are at high risk of bleeding complications from long-term anticoagulant use.13489
Eligibility Criteria
This trial is for adults with atrial fibrillation who are at high risk of stroke, even while on blood thinners. They should have a CHA2DS2-VASc score of 4 or more, indicating they're more likely to have a stroke. Participants must be willing to continue their current oral anticoagulant therapy throughout the study.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo endovascular left atrial appendage occlusion with the WATCHMAN device or receive standard medical care
Follow-up
Participants are monitored for safety and effectiveness, including assessment of ischemic stroke or systemic embolism
Treatment Details
Interventions
- WATCHMAN device (Procedure)