A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 610
- 试验地点
- 16
- 主要终点
- Device closure, defined as residual jet around the device ≤ 3mm
研究概览
简要总结
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
详细描述
The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Intended for LAAO with the Amulet device
- •At least 18 years of age
- •Willing and capable of providing informed consent and participating in all testing associated with this clinical study
排除标准
- •Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
结局指标
主要结局
Device closure, defined as residual jet around the device ≤ 3mm
时间窗: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
Composite endpoint: Death or complications
时间窗: Within 7 days of implant or hospital discharge, whichever is later
Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Composite endpoint: Ischemic stroke or systemic embolism
时间窗: Through 24 months
Composite of ischemic stroke or systemic embolism through 24 months
次要结局
未报告次要终点