A Pilot Study of Edoxaban in Patients with Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

Trial ID:
IRB-17-6931
Matthew Price
This is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically indicated WATCHMAN left atrial appendage (LAA) closure.

Inclusion Criteria:

  • The patient has documented paroxysmal, persistent, or permanent non-valvular AF (i.e., the patient has not been diagnosed with rheumatic mitral valve disease).
  • LAA closure with the WATCHMAN device is planned
  • The patient fulfills the FDA indication for WATCHMAN LAA closure
  • The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
  • The patient is able and willing to return for required follow-up visits and examinations.
  • The patient is 18 years of age or older

Exclusion Criteria:

  • Conditions other than atrial fibrillation that require anti-coagulation (e.g., a prosthetic heart valve)
  • Stroke within the previous 7 days
  • Hypersensitivity to edoxaban
  • Moderate or severe mitral stenosis
  • A need for aspirin at a dose of >81 mg a day
  • A need for on-going treatment with dual antiplatelet therapy with aspirin and clopidogrel
  • A need for on-going treatment with ticagrelor or prasugrel
  • No LAA closure device implanted during procedure
  • Procedural complication of LAA closure (e.g., stroke, systemic embolism, bleeding, vascular complication [e.g., groin hematoma >10cm, AV fistula, or pseudoaneurysm), or serious pericardial effusion)
  • Planned surgery or invasive procedure within 6±2 weeks of enrollment

Contact Info:

  • Catchpole Heather
  • Catchpole.Heather@scrippshealth.org
  • 858-824-4248

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