Background
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and the rate of ischemic stroke attributed to non‐valvular AF is estimated at 5% per year. Several multi‐center studies established left atrial appendage closure as a safe and effective alternative to oral anticoagulation, but there is a need for additional real world data.
Methods
The purpose of this observational, prospective, single‐arm, multicenter clinical study is to compile real‐world clinical outcome data for WATCHMAN™ LAA (left atrial appendage) Closure Technology. One thousand subjects at up to 70 institutions in Europe, the Middle East, and Russia will be enrolled. Patients will be followed for 2 years after WATCHMAN implantation, according to standard medical practice. Primary endpoints include procedural and long‐term data including stroke/embolism, bleeding, and death. This article presents the background of the LAAC device and describes the design of the study.
Results
Results for peri‐procedural analyses are expected toward the end of 2015; long‐term follow‐up data are expected in the latter half of 2017.
Conclusion
The EWOLUTION study will formally expand knowledge of LAA closure into a broader real world setting. © 2015 Wiley Periodicals, Inc.