Ewolution, 07-13 version AA
Research type
Research Study
Full title
EWOLUTION - REgistry on WATCHMAN Outcomes in Real-Life Utilization
IRAS ID
138492
Contact name
Tim Betts
Contact email
Sponsor organisation
Guidant Europe, a Boston Scientific Company
Research summary
Patients are being asked to take part in this study because they have a heart condition in which the upper chambers of their heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of the heart called the left atrial appendage (LAA). Everyone has a LAA, and it looks like a pouch on the top of the heart. If a clot forms, it can increase the chance of having a stroke or other related problems. Because of the atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to enter the blood. The WATCHMAN device is already registered and approved for use in the UK and is not investigational. The device is designed to be permanently implanted in the LAA of the heart. The WATCHMAN device closes the LAA so that any clots that may form there are not released into the blood stream. In this study, we will only collect standard information about the patient, the WATCHMAN device and its effects on the patient. This study will help us to better understand the clinical characteristics of patients who receive WATCHMAN device, which may be used in the future to improve the clinical care for patients with atrial fibrillation. The objective of the study is to compile real world clinical data on the use of the WATCHMAN LAA Closure Technology in a commercial clinical setting. There will be no additional visits, nor procedures for patients choosing to participate in the study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0618
Date of REC Opinion
24 Dec 2013
REC opinion
Favourable Opinion