FLXIBILITY
Research type
Research Study
Full title
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
IRAS ID
264929
Contact name
Timothy Betts
Contact email
Sponsor organisation
Boston Scientific
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Research Summary
The FLXibility study is designed to collect real world clinical outcomes data on WATCHMAN FLX in patients who are implanted with the WATCHMAN device in a commercial clinical setting.
The study aims to obtain clinical data on procedural success and complications, as well as information about long term patient outcomes, including clinical data on incidence of stroke/TIA, mortality and details on strokes especially
ischemic ones (kind of stroke, severity, disabling/non-disabling).Summary of Results
When used in everyday clinical practice, the WATCHMAN FLX device had an excellent rate of procedural success, high effective left artial appendage closure rates, and low serious adverse event rates. Summary is available in article: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba-2B7BqVsKuv6iku9MKiTsgu3ZaqZXLz184EfDVk0KkHSlgX9tSrgUTneQmrVfZKEvzg8mK1jVD4gQoGfFg-2Fuab4-3D64B-_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKjCalReygP7ycKrq895o8llu-2FK4lxZ32wc8Am9TcsG-2FSVGJroZxxHGk27nV7FV3d79a905rHntDsesuK6Jq4WxBp7X8f4KFmj8R4BCVxslDLRKq3eHdSkkcjwk7-2Fj8I7YX99-2Fc4Fm0kbeiDDDLIt3PZwI6y64Eglod3p3MZtEImw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cfe75d0b7540f44dbb32f08da537804ce%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637914072186511769%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=WKed5%2Ftwxk%2FKpw7qoUhL0wZjn2idAvtRuchSVQi%2BnPo%3D&reserved=0
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1217
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion