WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,857
- 试验地点
- 151
- 主要终点
- Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm
研究概览
简要总结
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
详细描述
This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):
- Aspirin only
- Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
- DAPT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Subject is of legal age to participate in the study per the laws of their respective geography.
- •Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
- •Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
- •The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
- •The subject is able and willing to return for required follow-up visits and examinations.
排除标准
- •Subject's device implant procedure was aborted (i.e., failed implant).
- •Subject has a device margin residual leak > 0mm at time of implant.
- •Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
- •Subject has a contraindication to one of the three protocol defined drug regimens.
- •Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
- •Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
- •Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
- •Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
- •Subject has Modified Rankin Score of ≥ 3 at baseline.
- •Subject has left ventricular ejection fraction (LVEF) < 30%.
- •Subject with known amyloid cardiomyopathy.
- •Platelet count ≤ 100,000 x 109/L.
- •Subject has an estimated glomerular filtration rate (eGFR) < 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
- •Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
- •Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization.
- •Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
- •Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
- •Subject has an active bleed.
- •Subject has a cardiac tumor.
- •Subject has signs/symptoms of acute or chronic pericarditis.
- •Subject has an active infection.
- •There is evidence of tamponade physiology.
- •Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
- •Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
- •Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
- •Subject has a documented life expectancy of less than 12 months.
研究组 & 干预措施
Aspirin
Aspirin 81-100 mg, daily post implant for duration of the clinical trial
干预措施: WATCHMAN FLX Pro LAAC Device (Device)
Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) for the first 3 months daily, post implant, followed by aspirin only for the duration of the clinical trial
干预措施: WATCHMAN FLX Pro LAAC Device (Device)
DAPT
DAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial
干预措施: WATCHMAN FLX Pro LAAC Device (Device)
结局指标
主要结局
Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm
时间窗: 6 months after randomization
Non Inferiority
Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm.
时间窗: 6 months after randomization
Non Inferiority
次要结局
未报告次要终点