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临床试验/NCT07132593
NCT07132593已完成不适用

A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年1月1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
17
试验地点
1
主要终点
composite endpoint

研究概览

简要总结

This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after resection of cardiac fibromas in children. Cardiac fibroma is a rare benign tumor that can compress vital cardiac structures and cause serious symptoms such as arrhythmia, heart failure, or obstruction of blood flow. Surgical removal is often required, but large tumors may leave defects in the heart wall that are challenging to repair, especially in young children.

The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding. This retrospective, observational study includes pediatric patients who underwent this procedure between 2018 and 2023. We report on its surgical feasibility, short- and mid-term outcomes, and potential benefits in preserving cardiac function.

研究设计

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

入排标准

年龄范围
— 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • underwent cardiac tumor resection
  • underwent ventricular reconstruction with the Sandwich Procedure

排除标准

  • the final pathological diagnosis indicated other than cardiac fibroma
  • the final pathological diagnosis indicated metastatic tumors
  • incomplete clinical or follow-up data

结局指标

主要结局

composite endpoint

时间窗: up to 5 years

all-cause mortality or cardiac reoperation

次要结局

  • ventricular failure(up to 5 years)
  • ventricular aneurysm(up to 5 years)
  • malignant arrhythmia(up to 5 years)
  • Heart block(up to 5 years)
  • severe perioperative complications(before discharge)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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