Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 40
- 主要终点
- Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)
研究概览
简要总结
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Paroxysmal, persistent or permanent non-valvular AF
- •Eligible for long-term warfarin therapy
- •Eligible to come off warfarin therapy
- •Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:
- •Female age 75 or older
- •Baseline LVEF ≥ 30 and < 35%
- •Aged 65-74 and has diabetes or coronary artery disease
- •Aged 65 or greater and has congestive heart failure
排除标准
- •Contraindicated/allergic to aspirin
- •Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
- •History of atrial septal repair or has an ASD/PFO device
- •Implanted mechanical valve prosthesis
- •NYHA Class IV CHF
- •Resting heart rate > 110 bpm
- •Participated previously in the PROTECT AF or CAP Registry studies
- •Key Echo Exclusion Criteria:
- •LVEF < 30%
- •Existing pericardial effusion > 2mm
- •High risk PFO
- •Significant mitral valve stenosis
- •Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- •Cardiac tumor
研究组 & 干预措施
WATCHMAN
Subjects assigned to receive the WATCHMAN device.
干预措施: WATCHMAN Device (Device)
Warfarin
Subjects assigned to warfarin therapy.
干预措施: Warfarin (Drug)
结局指标
主要结局
Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)
时间窗: 18 month rate
The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.
Composite of Ischemic Stroke or Systemic Embolism
时间窗: Day 8 to 18-months
Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization
Primary Safety Endpoint (Device Group Only)
时间窗: 7-Day
7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
次要结局
未报告次要终点