跳至主要内容
临床试验/NCT06526403
NCT06526403已完成不适用

Echocardiography-Guided Percutaneous Closure of Oval-Shaped Secundum Atrial Septal Defects

National Cardiovascular Center Harapan Kita Hospital Indonesia2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
Success rate

研究概览

简要总结

Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

详细描述

Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective

To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

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

性别
All
接受健康志愿者

入选标准

  • Oval-shaped secundum ASD with evidence of right ventricular overload, no significant and irreversible pulmonary arterial hypertension, no significant arrhythmia, no serious problems in other organs, and presumption of appropriate rims for device implantation

排除标准

  • Other than stated in inclusion criteria

结局指标

主要结局

Success rate

时间窗: five years

次要结局

未报告次要终点

研究者

发起方
National Cardiovascular Center Harapan Kita Hospital Indonesia
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验