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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Edoxaban 60mg once daily in patients with CrCl \>50- ≤95 mL/min, or 30mg once daily in patients with CrCL 15-50 mL/min. If at 6 week TEE LAA closure is deemed acceptable by the operator (i.e., peri-device flow \<5mm), edoxaban will be discontinued. Aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up, then clopidogrel will be discontinued. If LAA unacceptable on 6-week TEE due to peri-device flow ≥5mm, edoxaban will be continued for an additional 6 weeks, and LAA reassessed by TEE If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference.
Per Inclusion Criteria, enrolled subjects must have a successful Left Atrial Appendage (LAA) Closure using the WATCHMAN Device
Scripps Health
La Jolla, California, United States
RECRUITINGDeath, stroke, systemic embolism or GUSTO outcomes
Composite of death, stroke, systemic embolism, or GUSTO moderate/severe bleeding will be collected at 6 weeks post-WATCHMAN LAA closure
Time frame: 6 weeks
Death, stroke, or systematic embolism outcomes
Composite of death, stroke, or systemic embolism at 6 weeks and 6 months
Time frame: 6 weeks and 6 months
Death, stroke, or systematic embolism or GUSTO outcomes
Composite of death, stroke, systemic embolism or GUSTO moderate/severe bleeding at 6 months
Time frame: 6 months
Device thrombus oucomes
TEE-confirmed device thrombus (according to core laboratory) at 6 weeks
Time frame: 6 weeks
TEE peri-device flow outcomes
Rate of peri-device flow \>=5mm at 6 week follow-up TEE
Time frame: 6 weeks
GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding outcomes
Individual endpoints of GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding at 6 weeks and 6 months
Time frame: 6 weeks and 6 months
Premature discontinuation rate of study drug
Premature discontinuation rate of study drug before 6-week visit
Time frame: 6 weeks
Bleeding outcomes
Bleeding according to the months Bleeding Academic Research Consortium (BARC) criteria at 6 weeks and 6 months
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If at 6 week TEE LAA closure is deemed acceptable by the operator edoxaban will be discontinued, and aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up. Then clopidogrel will be discontinued. Aspirin 325mg daily rather than 81mg daily can be administered according to operator preference after the 6-week follow-up visit.
If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference.
Time frame: 6 weeks and 6 months