Long-term Follow-up on LAA Exclusion Using AtriClip, VCLIP Post-Market Study, CLINICAL TRIAL PROTOCOL: CP-2021-03
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 22
- 主要终点
- Primary Performance Endpoint
研究概览
简要总结
Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.
详细描述
The goal of this clinical trial is to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures in participants for which a VCLIP was placed previously. Participants are consented and evaluated to confirm long-term performance of the AtriClip®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Subject is greater than or equal to 18 years of age.
- •Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure
- •Subject is willing and able to provide written informed consent
- •Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE)
排除标准
- •Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
- •Subjects who are pregnant or breast feeding
- •Subjects with active COVID-19 infection
结局指标
主要结局
Primary Performance Endpoint
时间窗: 12-months or greater post-procedure, an average of 1.5 years
Left Atrial Appendage exclusion defined as absence of residual communication (≤3 mm residual communication with LAA) between the left atrium (LA) and the LAA as assessed by CTA or TEE imaging at the last follow-up visit. The images will be reviewed by an independent core lab using a standardized imaging protocol.
Primary Safety Endpoint
时间窗: 30-days post-procedure
Incidence of the following serious adverse events within 30-days, if related tot he device and/or implant procedure: * Death * Ischemic Stroke * Transient Ischemic Attack * Systemic Embolism * Hemorrhagic Stroke * Major Bleeding (BARC 3 and above) * Surgical site infection * Pericardial effusion requiring intervention * Clinical diagnosis of myocardial infarction
次要结局
- Performance(12-months or greater post-procedure, an average of 1.5 years)
- Long-term Thromboembolic Events(12-months or greater post-procedure, an average of 1.5 years)
- Device and Procedure Long-term Safety(12-months or greater post-procedure, an average of 1.5 years)