A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
- Conditions
- Left Atrial Appendage ClosureNon-Valvular Atrial Fibrillation
- Interventions
- Registration Number
- NCT03088072
- Lead Sponsor
- Scripps Health
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Edoxaban Arm Aspirin and Warfarin 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. Edoxaban Arm WATCHMAN LAA Closure 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. Edoxaban Arm Aspirin and Clopidogrel 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. Edoxaban Arm Edoxaban 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.
- Primary Outcome Measures
Name Time Method Death, stroke, systemic embolism or GUSTO outcomes 6 weeks Composite of death, stroke, systemic embolism, or GUSTO moderate/severe bleeding will be collected at 6 weeks post-WATCHMAN LAA closure
- Secondary Outcome Measures
Name Time Method Death, stroke, or systematic embolism outcomes 6 weeks and 6 months Composite of death, stroke, or systemic embolism at 6 weeks and 6 months
Death, stroke, or systematic embolism or GUSTO outcomes 6 months Composite of death, stroke, systemic embolism or GUSTO moderate/severe bleeding at 6 months
Device thrombus oucomes 6 weeks TEE-confirmed device thrombus (according to core laboratory) at 6 weeks
TEE peri-device flow outcomes 6 weeks Rate of peri-device flow \>=5mm at 6 week follow-up TEE
GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding outcomes 6 weeks and 6 months Individual endpoints of GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding at 6 weeks and 6 months
Premature discontinuation rate of study drug 6 weeks Premature discontinuation rate of study drug before 6-week visit
Bleeding outcomes 6 weeks and 6 months Bleeding according to the months Bleeding Academic Research Consortium (BARC) criteria at 6 weeks and 6 months
Trial Locations
- Locations (1)
Scripps Health
🇺🇸La Jolla, California, United States