REFLX
Research type
Research Study
Full title
Procedure RElated outcomes with the Watchman FLX left atrial appendage closure device
IRAS ID
194122
Contact name
Tim R Betts
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
Atrial fibrillation (AF) is a common heart rhythm disturbance. AF can cause blood clots to form in part of the heart called the left atrial appendage. These blood clots can then be pumped out of the heart, into the brain, causing a stroke.
In patients identified as high risk of stroke, the usual treatment is oral anticoagulation which is medication used to "thin the blood" and prevent clots. Unfortunately, a proportion of people on oral anticoagulants have suffered severe, life-threatening bleeding problems, prohibiting their use. In this situation there is a new, minimally-invasive treatment called percutaneous left atrial appendage occlusion. This is a 60-90 minute operation performed by trained cardiologists. A plug is inserted into the mouth of the left atrial appendage, sealing it from the circulation. In trials this has been shown to be as effective as oral anticoagulation at lowering the risk of stroke but without increasing the long-term bleeding risk. In England it is approved for use in 10 centres, including Oxford, for selected patients. All left atrial appendage occlusion device procedures have anonymous procedure and followup data submitted to a central database for national audit purposes.
The Watchman device, manufactured by Boston Scientific has randomised controlled trial data on its effectiveness. The latest model of Watchman is called the Watchman FLX. It has been CE marked and will become the device of choice for implants in England from November 2015. There are a number of subtle design changes aimed at increasing the ease of implantation. Its use has been approved by the OUH NHS Trust New Technologies Group.
This study is a prospective data collection exercise that seeks to describe the initial experience with the Watchman FLX. All patients will be having the FLX inserted as part of standard care.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0064
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion