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

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

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.

This is a single site, PI initiated pilot study. This study will enroll up to 75 patients who are clinically indicated for a Left Atrial Appendage (LAA) closure with the commercially available WATCHMAN device. Subjects will be enrolled if they meet study inclusion/exclusion criteria and have a successful LAA closure. All patients enrolled in the study will receive 6 weeks of edoxaban therapy. At 6 weeks post LAA closure a Transesophageal Echocardiography (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. 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.

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