Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Successful subxiphoid needle access without myocardial injury
研究概览
简要总结
We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.
详细描述
The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. Subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during Lariat risks injury to the heart surface that requires surgical repair.
In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. Before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. The investigators then inject gas to push the heart away from the pericardial needle. This reduces the risk of injuring the heart during the standard Lariat procedure.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing subxiphoid access to the "empty" pericardial space as part of a Lariat left atrial appendage exclusion procedure
- •Age ≥ 21 years
排除标准
- •Does not consent to participate
研究组 & 干预措施
Pericardial insufflation with CO2
Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium
干预措施: Pericardial insufflation with carbon dioxide through a transatrial microcatheter (Procedure)
结局指标
主要结局
Successful subxiphoid needle access without myocardial injury
时间窗: Immediate
次要结局
未报告次要终点
研究者
Adam Greenbaum
Co-Director, Structural Heart Disease Program
Henry Ford Health System
