CHAMPION-AF

  • Research type

    Research Study

  • Full title

    WATCHMAN FLX versus NOAC for EMbolic ProtectION in the Management of Patients with Non-Valvular Atrial Fibrillation

  • IRAS ID

    287122

  • Contact name

    Timothy Betts

  • Contact email

    tim.betts@ouh.nhs.uk

  • Sponsor organisation

    Boston Scientfic Corporation

  • Clinicaltrials.gov Identifier

    NCT04394546

  • Clinicaltrials.gov Identifier

    G200106, IDE No

  • Duration of Study in the UK

    7 years, 7 months, 0 days

  • Research summary

    The Champion AF study is designed to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to Direct Oral Anticoagulant (NOACs) in patients with non-valvular atrial fibrillation.

    Patients in this study will be randomized to either receive the WATCHMAN FLX Device or a course of NOACs patients will be assessed over a period of up to 5 years.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    20/EE/0237

  • Date of REC Opinion

    28 Jan 2021

  • REC opinion

    Further Information Favourable Opinion