Conditions: Atrial Fibrillation Stroke
Keywords: atrial fibrillation stroke TIA trans ischemic attack warfarin Coumadin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 407
Healthy volunteers: no

Brief summary:
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Detailed description:

Arms:
arm 1: Subjects assigned to receive the WATCHMAN device. arm 2: Subjects assigned to warfarin therapy.

Interventions: intervention 1: WATCHMAN Device intervention 2: Warfarin
Intervention descriptions: intervention 1: WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Protocol document: