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

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.