FLXIBILITY

• Research type

  Research Study

• Full title

  Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

• IRAS ID

  189578

• Contact name

  Elisa Vireca

• Contact email

  elisa.vireca@bsci.com

• Sponsor organisation

  Boston Scientific

• Duration of Study in the UK

  3 years, 8 months, 30 days

• 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).

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  15/EM/0574

• Date of REC Opinion

  17 Dec 2015

• REC opinion

  Favourable Opinion