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Studies

Interventional Active not recruiting

NCT04676880 on ClinicalTrials.gov

Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy

Official title: Comparing Effectiveness and Safety of Left Atrial Appendage Occlusion for Non-valvular Atrial Fibrillation Patients at High Stroke Risk Unable to Use Oral Anticoagulation Therapy

  • Sponsor: R&D Cardiologie
  • Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
  • Enrollment: 609 (Estimated)
  • Study start: 2021-01-01 (Actual)
  • Primary completion: 2026-05-01 (Estimated)
  • Study completion: 2026-11-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This trial is set-up as an open-label, national multicentre, superiority randomized controlled trial where patients will be randomized in a 2:1 fashion to the device arm or the usual care arm.
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusion (LAAO) may provide a non-inferior alternative for cardioembolic stroke protection in patients tolerant to OAC. However, RCT data for LAAO is lacking in patients with contra-indications to OAC using antiplatelet (APT) or no therapy as usual care. The hypothesis underlying this trial is to demonstrate that LAAO is superior to usual care for the prevention of stroke.

Conditions

  • Atrial Fibrillation
  • Anticoagulants and Bleeding Disorders

Intervention / Treatment

  • Device: Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)

Primary Outcome Measures

  • Time to first occurrence of ischemic or hemorrhagic or undetermined stroke. (Minimal follow up is 1 year, maximum follow up +/- 5 years)
  • Time to first occurrence of the composite of stroke (ischemic or hemorrhagic or undetermined), TIA and systemic embolism. (Minimal follow up is 1 year, maximum follow up +/- 5 years)
  • Incidence of procedural complications (Procedure up to 30 days)
    Defined as major procedure-related events that require prolonged hospitalization and/or specific treatment, or that lead to permanent physical or mental disability, including but not limited to: pericardiocentesis, major access site bleeding (BARC), any other major bleeding (BARC), device dislocation from the LAA to the heart or aorta, stroke, death, or other severe complications that are considered due to the procedure

Countries

Netherlands

Locations and Investigators

  • Medical Center Leeuwarden, Leeuwarden, Netherlands
  • Radboud UMC, Nijmegen, Netherlands
  • Maastricht UMC, Maastricht, Netherlands
  • St Antonius Hospital, Nieuwegein, Netherlands
  • Amphia Hospital, Breda, Netherlands
  • OLVG, Amsterdam, Netherlands
  • Amsterdam UMC, Amsterdam, Netherlands
  • Medical Spectrum Twente, Enschede, Netherlands
  • Isala Clinics, Zwolle, Netherlands
  • Haga Hospital, Den Haag, Netherlands
  • Leiden UMC, Leiden, Netherlands
  • Erasmus MC, Rotterdam, Netherlands
  • UMC Groningen, Groningen, Netherlands
  • UMC Utrecht, Utrecht, Netherlands

Study Officials

  • Lucas VA Boersma, Prof. Dr. (Principal Investigator) — St Antonius Ziekenhuis Nieuwegein