跳至主要内容
临床试验/NCT02601768
NCT02601768Unknown不适用

Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment

National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Correlation between the proposed and actual device size.

研究概览

简要总结

The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.

详细描述

A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASD II suitable for percutaneous treatment
  • free and informed consent to analyze the medical data of the person concerned
  • age: patients over 16

排除标准

  • ASD II not suitable for percutaneous treatment
  • any valvular heart disease requiring cardiac surgery
  • no free and informed consent to analyze the medical data of the person concerned
  • age: under 16

结局指标

主要结局

Correlation between the proposed and actual device size.

时间窗: 18 months

The correlation will be analyzed after the data of the whole group has been completed.

次要结局

  • Success rate of the procedure(12 months)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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