Loading…
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
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 anticoagul...
Saved in:
Published in: | Catheterization and cardiovascular interventions 2016-09, Vol.88 (3), p.460-465 |
---|---|
Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Summary: | 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. |
---|---|
ISSN: | 1522-1946 1522-726X |
DOI: | 10.1002/ccd.26358 |