跳至主要内容
临床试验/NCT05709275
NCT05709275终止不适用

Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
6
试验地点
1
主要终点
Mortality during the hospital stay and after the discharge

研究概览

简要总结

This project has several objectives ranging from clinical data analysis to computational simulations as listed below:

  1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on:
  • Mortality;
  • Occurrence of adverse events;
  • Outcome of the three-staged palliation;
  1. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.

排除标准

  • Patients with any type of atrioventricular discordance.
  • Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato before March 2019.

结局指标

主要结局

Mortality during the hospital stay and after the discharge

时间窗: 5 year

death, cardiovascular arrest

次要结局

  • Number of adverse events registered during the follow-up.(5 year)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Saracino

Principal Investigator

IRCCS Policlinico S. Donato

研究点 (1)

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