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临床试验/NCT03961490
NCT03961490已完成不适用

Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure

研究概览

简要总结

Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the population. One of the major complications is the occurrence of thromboembolic events, the thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is therefore almost always indicated, however, in view of the target population, anticoagulant treatment is sometimes contraindicated, justifying the appearance of alternative treatment such as occlusion of the left auricle by surgical or percutaneous means, with the placement of a prosthesis in the left auricle.

Image fusion is a new imaging technique aimed at improving the spatial view of 2D images (made during a catheterization session) by repositioning in real time a 3D model obtained by reconstruction from scanner images of the structure of interest. Once the model has been redesigned, it follows all the consequences that the hemodynamicist wants to take and thus guides the gesture as well as possible.

The purpose of this project is to evaluate the contribution of image fusion to per cutaneous occlusion procedures of the left atrium. This contribution will be evaluated by comparing the procedure time, the irradiation time, the amount of contrast material used between the procedures performed with the image fusion technique and without this new technique.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patient
  • Patient with a collegially selected indication of FAG
  • Patient willing to participate in the study

排除标准

  • Minors, adults under guardianship and protected persons
  • Presence of contraindications to the procedure, including the presence of a thrombus in the left atrium
  • Procedure combined with another percutaneous gesture at the same time

结局指标

主要结局

evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure

时间窗: 3 years

the surface dose product (PDS) in centigray centimetres squared (cGy.cm²)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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