A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
研究概览
简要总结
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.
详细描述
The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
- •18 years of age or older
- •LAA anatomy amenable to treatment by percutaneous techniques
- •Risk factors for potential thrombus formation in the LAA
- •Willing to participate in the required follow-up visits and tests
- •Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site
排除标准
- •Known contraindication to percutaneous transseptal intervention
- •Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
- •Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
- •Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
- •Known contraindication and/or allergy to nickel
- •Known active bacterial infection (i.e., sepsis, endocarditis)
- •Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests.
- •Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
研究组 & 干预措施
WaveCrest®
Implant of WaveCrest® Left Atrial Appendage Occlusion System
干预措施: Percutaneous LAA Closure (Device)
WaveCrest®
Implant of WaveCrest® Left Atrial Appendage Occlusion System
干预措施: Anticoagulation or Clopidogrel (Drug)
结局指标
主要结局
Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
时间窗: From baseline up to 45 days
The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
次要结局
- Percentage of Participants Who Achieved Device Success(From baseline up to 45 days)
- Percentage of Participants Who Achieved Technical Success(From baseline up to 45 days)
- Percentage of Participants Who Achieved Procedural Success(From baseline up to 45 days)