title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  The EWOLUTION study will formally expand knowledge of LAA closure into a broader real world setting. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands. l.boersma@antoniusziekenhuis.nl.
authors.forename: Lucas V A
authors.initials: LV
authors.lastname: Boersma
authors.affiliation: Department of Cardiology, Cardioangiologisches Centrum Bethanien, Frankfurtt, Germany.
authors.forename: Boris
authors.initials: B
authors.lastname: Schmidt
authors.affiliation: Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom.
authors.forename: Tim R
authors.initials: TR
authors.lastname: Betts
authors.affiliation: Department of Cardiology, Cardio Vasculäres Centrum Sankt Katharinen, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Department of Cardiology, Ospedale Ferrarotto Alessi, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Department of Cardiology, CHU Henri Mondor, Créteil, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.affiliation: Department of Cardiology, Boston Scientific Corp, Minneapolis, USA.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Stein
authors.affiliation: Department of Cardiology, Herzkatheter Asklepios Wandsbek, Hamburg, Germany.
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
mesh_terms: D020517:Atrial Appendage / Q000000981:diagnostic imaging / Q000503:physiopathology; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005060:Europe; D006801:Humans; D008877:Middle East; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
keywords: cardiac embolus; cerebrovascular accident; prevention