This study, called LAAOS-4, is testing if a device called WATCHMAN can prevent strokes or blood clots (systemic embolism) in people with atrial fibrillation (an irregular heartbeat). You might be able to join if you have persistent or permanent atrial fibrillation, or paroxysmal atrial fibrillation (irregular heartbeat that comes and goes) and have had a stroke or blood clot before. You also need to have a high risk of stroke, even if you're already taking blood thinners. The study will consider the WATCHMAN device successful if it reduces the number of strokes or blood clots over an average of 4 years. The current enrollment status is unclear.

Study design

This is a randomized controlled trial, meaning participants will be randomly assigned to different groups. It's an open-label study, so you and your doctors will know which treatment you receive, and aims to enroll 4000 participants.

What's involved

Participants will undergo a procedure to implant the WATCHMAN device. The study duration is event-driven, with the primary analysis occurring once 265 primary events happen, estimated to be an average of 4 years.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for an estimated average of 4 years, until 265 primary efficacy endpoint events have occurred.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.