Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Ischemic stroke
研究概览
简要总结
The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.
详细描述
An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.
Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.
As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Watchman FLX LAAO
- •A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
- •A minimum of one year clinical follow-up data
排除标准
- 未提供
结局指标
主要结局
Ischemic stroke
时间窗: Minimum 12 months
Clinically affirmed ischemic stroke
次要结局
- Device-related thrombosis(Minimum 12 months)
- Major bleeding(Minimum 12 months)
- All-cause and cardiovascular mortality(Minimum 12 months)
研究者
Anders Kramer
MD, PhD-fellow
Aarhus University Hospital