WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 62
- 主要终点
- Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
研究概览
简要总结
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
详细描述
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
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
- 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
- •Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- •Eligible for long term warfarin
- •CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]
排除标准
- •Contraindicated for warfarin
- •Contraindicated for aspirin or clopidogrel (Plavix)
- •Congestive heart failure (CHF) Class 4
- •Implanted mechanical valve
- •Atrial septal or Patent Foramen Ovale (PFO) device
- •Platelets < 100,000 or hemoglobin < 10
- •Left ventricular ejection fraction (LVEF) < 30%
研究组 & 干预措施
WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
干预措施: WATCHMAN Left Atrial Appendage Closure Technology (Device)
Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
干预措施: Warfarin (Drug)
Roll-in
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
干预措施: WATCHMAN Left Atrial Appendage Closure Technology (Device)
结局指标
主要结局
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
时间窗: 5 years
A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years)
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
时间窗: 5 years
Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
次要结局
- Procedure Success(Initial implant procedure)