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

Scripps Health

Status and phase: Unknown; Phase 4

Conditions: Left Atrial Appendage Closure; Non-Valvular Atrial Fibrillation

Treatments: Drug: Aspirin and Warfarin; Drug: Aspirin and Clopidogrel; Drug: Edoxaban; Device: WATCHMAN LAA Closure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03088072

IRB-17-6931

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Edoxaban Arm

Other group

Description:

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.

Treatment:

Drug: Aspirin and Warfarin

Drug: Aspirin and Clopidogrel

Drug: Edoxaban

Device: WATCHMAN LAA Closure