Amulet IDE

  • Research type

    Research Study

  • Full title

    Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

  • IRAS ID

    220087

  • Contact name

    Mark Spence

  • Contact email

    mark.spence@belfasttrust.hscni.net

  • Sponsor organisation

    St. Jude Medical

  • Clinicaltrials.gov Identifier

    NCT02879448

  • Duration of Study in the UK

    1 years, 7 months, 1 days

  • Research summary

    The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder. Recruits will be randomized in a 1:1 ratio between the Amulet LAA occlusion device and the Boston Scientific LAA closure device.

  • REC name

    HSC REC A

  • REC reference

    17/NI/0208

  • Date of REC Opinion

    8 Dec 2017

  • REC opinion

    Further Information Favourable Opinion