跳至主要内容
临床试验/NCT06584370
NCT06584370已完成不适用

Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Greenbaum

Co-Director, Structural Heart Disease Program

Henry Ford Health System

研究点 (1)

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