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临床试验/NCT04234711
NCT04234711Unknown不适用

Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Incidence rate of postoperative pulmonary venous obstruction (PVO)

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

详细描述

An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.

Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

研究设计

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

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants and neonates who are diagnosed with TAPVC
  • Infants and neonates who undergo initial surgical repair for TAPVC.

排除标准

  • Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
  • Older than 1-year-old.

结局指标

主要结局

Incidence rate of postoperative pulmonary venous obstruction (PVO)

时间窗: 2 years

in anastomosis or arborizations of pulmonary veins

Mortality rate

时间窗: 2 years

all causes and surgical repair related

次要结局

  • Development of all kinds of arrhythmia(2 years)
  • The scores of postoperative quality of life: rating scale(2 years)
  • Change in resting oxygen saturation(2 years)
  • Value of tricuspid annular plane systolic excursion(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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