WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest® Left Atrial Appendage Occlusion System Compared to the Watchman® LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 248
- 试验地点
- 25
- 主要终点
- Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
研究概览
简要总结
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
详细描述
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA occlusion system). The trial is designed to demonstrate that safety and effectiveness of the WaveCrest device are non-inferior to the Watchman device.
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)
盲法说明
If the subject is suspected of having a stroke since their most recent follow-up, a Neurologist blinded to subject's randomization and implanted device must evaluate the subject or otherwise provide rationale for why an in-person neurology visit and exam are unnecessary. Neurology or blinded trial personnel should also administer mRS & NIHSS if there is suspicion of stroke A Clinical Events Committee, also blinded to subject's randomization, will adjudicate primary safety and effectiveness.
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
- •Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- •At least 18 years of age
- •Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3
- •Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
- •Willing and able to comply with post-implant anticoagulation and antiplatelet regimen
- •Willing to participate in the required follow-up visits and tests
- •Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB/EC at the site
排除标准
- •Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or postoperative)
- •Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be adequately pre-medicated or desensitized
- •Conditions other than AF requiring long-term anticoagulation therapy
- •Contraindications for percutaneous catheterization procedures
- •Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures
- •Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
- •Inability or unwillingness to take oral anticoagulation for 45 days post-procedure
- •New York Heart Association (NYHA) Class IV heart failure
- •Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
- •History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms > 6 months
- •Modified Rankin Scale (mRS) score ≥ 4
- •Chronic resting heart rate ≥ 110 bpm
- •Congenital cardiac anomalies requiring cardiac surgery or interventional repair
- •Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment
- •Myocardial infarction within 60 days prior to enrollment
- •Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment
- •Surgical or interventional cardiovascular and non-cardiovascular procedure including cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior to enrollment or any planned general surgery or interventional procedure within 90 days after enrollment or any planned cardiac surgery.
- •On renal replacement therapy, serum creatinine > 3.0 mg/dl (265 μmol/L) or calculated creatinine clearance < 25 ml/minute
- •Thrombocytopenia (<60,000 platelets/mm3), leucopenia (white blood cell count < 3,000 cells/mm³), or anemia (hemoglobin concentration < 10 grams/deciliter) based on blood work done within 30 days prior to enrollment
- •Any medical disorder or psychiatric illness that would interfere with successful completion of the trial
- •Currently participating in an investigational drug trial or another device trial that has not completed the primary endpoint (trials requiring extended follow-up for products that are commercially available are not considered investigational trials). Concurrent enrollment in the ACC LAAO Registry is permitted.
- •Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)
- •Any condition that would reduce life expectancy to less than 2 years
- •Women of childbearing potential who are, or plan to become pregnant during the time of the trial (method of assessment per physician discretion)
- •Echocardiographic Exclusion Criteria
- •Left ventricular ejection fraction < 30%
- •Mitral valve stenosis defined as valve area < 1.5cm2, mean gradient > 6mmHg, or any valve deformity consistent with rheumatic valvular disease
- •Aortic valve stenosis defined as valve area ≤1.0cm2 or mean gradient >30mmHg
- •Circumferential pericardial effusion > 10mm or symptomatic pericardial effusion
- •Evidence of intracardiac thrombus
- •Cardiac tumor or myxoma
- •Atrial septal defect that warrants closure
- •Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque
- •Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or Watchman device
研究组 & 干预措施
WaveCrest
WaveCrest left atrial appendage occluder
干预措施: Coherex WaveCrest® Left Atrial Appendage Occlusion System (Device)
Watchman (control)
Watchman left atrial appendage closure device
干预措施: Watchman® LAA Closure Device (Device)
结局指标
主要结局
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
时间窗: All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months
The primary safety outcome was the composite of death from any cause (all-cause mortality), procedure or device related complications requiring percutaneous or surgical intervention through 45 days post procedure or major bleeding throughout the duration of the trial. The analysis was based on sponsor assessment of adverse events data. Baseline was defined as 90 day prior to treatment or 90 days prior to randomization; baseline assessments could occur on the day of implant.
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months
时间窗: At 24 months
Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.
次要结局
- Percentage of Participants With Ischemic Stroke or Systemic Embolism With the WAVECREST Device in Comparison to the CHADS2 and CHA2DS2-VASc Imputed Risk of Ischemic Stroke or Systemic Embolism in the Absence of Anticoagulant Therapy(At 45 days)
- Percentage of Participants With Left Atrial Appendage (LAA) Closure(At 45 days)