Conditions: Atrial Fibrillation Stroke
Keywords: Atrial Fibrillation AF A Fib Stroke Coumadin Warfarin Blood thinning medication transient ischemic attack (TIA) WATCHMAN Left atrial appendage LAA isolation LAA occlusion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 800
Healthy volunteers: no

Brief summary:
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Detailed description:
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Arms:
arm 1: Implant of WATCHMAN Left Atrial Appendage Closure Technology arm 2: Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin arm 3: Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.

Interventions: intervention 1: WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Warfarin
Intervention descriptions: intervention 1: Implant of WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Subjects receive warfarin

Protocol document: