AMPLATZER™ Amulet™ Observational Post-Market Study

• Research type

  Research Study

• Full title

  AMPLATZER™ Amulet™ Observational Post-Market Study Clinical Protocol

• IRAS ID

  181497

• Contact name

  Julie Choate

• Contact email

  jchoate@sjm.com

• Sponsor organisation

  St Jude Medical

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  This observational study is designed to collect outcome data on patients who have the Amulet left atrial appendage plug implanted.

  The patient population is non-valvular atrial fibrillation patients who are at risk of thromboembolic events (stroke or blood clots).

  A total of 1000 subjects will be recruited at 75 sites (hospital cardiology departments) throughout Europe, Middle East, Australia, New Zealand, Latin America and the Asia-Pacific region.

  Participants who are scheduled to have the Amulet device implanted are eligable subject to the study inclusion/exclusion criteria being met.

  The recruitment period is two years and the follow-up period for each participant is two years. The study patient schedule is baseline testing, device implant, pre-hospital discharge assessment follow-ups at 6 weeks, 6 months, 12 months and 24 months.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  15/LO/1324

• Date of REC Opinion

  23 Oct 2015

• REC opinion

  Further Information Favourable Opinion