A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
Non-Valvular Atrial Fibrillation, Left Atrial Appendage Closure
About this trial
This is an interventional treatment trial for Non-Valvular Atrial Fibrillation focused on measuring Edoxaban, WATCHMAN device
Eligibility Criteria
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
Sites / Locations
- Scripps HealthRecruiting
Arms of the Study
Arm 1
Other
Edoxaban Arm
All patients enrolled in the study will receive 6 weeks of edoxaban therapy, at which time a TEE will be performed. If the result is acceptable, edoxaban will be discontinued, and the patient will be treated with dual antiplatelet therapy (aspirin and clopidogrel) until 6 month follow-up. If device thrombus is present at 6 week TEE, patient will be transitioned to aspirin and adjusted-dose warfarin and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference. Subjects will have a 6 month follow-up visit prior to study completion. After study completion, patients may be treated with aspirin monotherapy according to the FDA instructions for use for the WATCHMAN device, or according to operator discretion.