Trial Number
492-24
Conditions
Atrial Fibrillation, Stroke
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)”
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.
Individuals who agree to participate in the study will be randomized (assigned by chance) to the anticoagulation PLUS Watchman device arm or anticoagulation alone. After enrollment, study visits will occur every 6 months. Patients assigned to receive the WATCHMAN TM Device will have an extra visit for the procedure, and may also have an extra 1 or 2 in-person follow-up visits after the procedure to check on the device. Study visits can be completed by telephone or in person during a regular visit.