A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Death, stroke, systemic embolism or GUSTO outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Edoxaban (Drug)
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.
干预措施: WATCHMAN LAA Closure (Device)
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.
干预措施: Aspirin and Clopidogrel (Drug)
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.
干预措施: Aspirin and Warfarin (Drug)
结局指标
主要结局
Death, stroke, systemic embolism or GUSTO outcomes
时间窗: 6 weeks
Composite of death, stroke, systemic embolism, or GUSTO moderate/severe bleeding will be collected at 6 weeks post-WATCHMAN LAA closure
次要结局
- Device thrombus oucomes(6 weeks)
- Death, stroke, or systematic embolism outcomes(6 weeks and 6 months)
- Death, stroke, or systematic embolism or GUSTO outcomes(6 months)
- TEE peri-device flow outcomes(6 weeks)
- GUSTO mild, moderate, severe, and GUSTO moderate/severe bleeding outcomes(6 weeks and 6 months)
- Premature discontinuation rate of study drug(6 weeks)
- Bleeding outcomes(6 weeks and 6 months)
研究者
Matthew J Price
Principal Investigator
Scripps Health