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临床试验/NL-OMON44674
NL-OMON44674已完成不适用

The role of the pulmonary vasculature in the Fontan circulation - Fontan HC

niversitair Medisch Centrum Groningen0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Fontan group:
  • - written informed consent
  • - Patients who underwent a TCPC/Fontan procedure
  • - Follow-up at UMCG
  • - adult 18 years or older
  • - Clinical indication for cardiac catheterization;Control group:
  • - written informed consent
  • - absence of Fontan circulation or univentricular heart-like diagnosis
  • - Follow-up at UMCG
  • - adult 18 years or older
  • - clinical indication for right heart catheterization
  • - absence of pulmonary vascular diseases
  • - normal pulmonary vascular hemodynamic profile;PAH group
  • - Written informed consent
  • - Clinical indication for right heart catheterization
  • - History of pulmonary arterial hypertension [PAH] diagnosis (criteria; mean pulmonary artery pressure > 25mmHg, pulmonary capillary wedge pressure <15mmHg, pulmonary vascular resistance index > 3 wood units, and other possible causes for pulmonary hypertension excluded).
  • - Reconfirmation of PAH diagnosis based on hemodynamic criteria during the right heart catheterization.

排除标准

  • Fontan group:
  • - Standard exclusion criteria for cardiac catheterization
  • - Obstruction in Fontan conduit
  • - Inability to measure a reliable cardiac index and PVR (rhythm instability, hemodynamic or anatomic reasons);Control group:
  • - No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization;PAH group
  • - No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization.
  • - Inability to perform a pulmonary OCT measurement during right catheterization (rhythm instability, hemodynamic or anatomic reasons)

研究者

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