EWOLUTION: Design of a registry to evaluate real-world clinical outcomes in patients with AF and high stroke risk-treated with the WATCHMAN left atrial appendage closure technology

• Published in: Catheterization and cardiovascular interventions Vol. 88; no. 3; pp. 460 - 465
• Main Authors: Boersma, Lucas V.A., Schmidt, Boris, Betts, Tim R., Sievert, Horst, Tamburino, Corrado, Teiger, Emmanuel, Stein, Kenneth M., Bergmann, Martin W.
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.09.2016; Wiley Subscription Services, Inc
• Subjects: Atrial Appendage - diagnostic imaging; Atrial Appendage - physiopathology; Atrial Fibrillation - complications; Atrial Fibrillation - diagnosis; Atrial Fibrillation - physiopathology; Atrial Fibrillation - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - methods; cardiac embolus; cerebrovascular accident; Europe; Humans; Middle East; prevention; Product Surveillance, Postmarketing; Prospective Studies; Registries; Research Design; Risk Assessment; Risk Factors; Stroke - diagnosis; Stroke - etiology; Stroke - prevention & control; Time Factors; Treatment Outcome; cardiac embolus; cerebrovascular accident; prevention
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.26358

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.