LeAAPS Trial CP-2021-05

  • Research type

    Research Study

  • Full title

    Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial LeAAPS Trial



  • Contact name

    Rebecca Ikura

  • Contact email


  • Sponsor organisation

    AtriCure, Inc

  • Clinicaltrials.gov Identifier


  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    9 years, 0 months, 1 days

  • Research summary

    The aim of this trial is to demonstrate the effectiveness of LAA exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

    Approximately 6500 subjects will be enrolled at approximately 250 U.S. and International sites, who are 18 years of age or older, undergoing planned cardiac surgery, without documented clinical diagnosis of atrial fibrillation (Where the heart beats irregulary), who also present with documented risk factors for developing atrial fibrillation and ischemic stroke.

    Subjects will be randomized either to the Treatment arm (LAAE concomitant to cardiac surgery) or the Control arm (cardiac surgery procedure without LAAE). The trial will be blinded. This means that the participants and most of the research staff will not know which arm the participant has been allocated to.

    All subjects will be followed for a minimum of 5 years post index cardiac surgery, which can be performed remotely via telemedicine appointments. Follow ups will include a structured interview and use of validated questionnaires.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference


  • Date of REC Opinion

    21 Dec 2023

  • REC opinion

    Further Information Favourable Opinion