JPRN-jRCTs052210139进行中(未招募)1 期
Prospective and interventional research on the development of a multi-scale and multi-physics cardiac simulator ped UT-Heart - ped UT-Heart
Kurosaki Kenichi0 个研究点目标入组 15 人开始时间: 2021年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 15age old(—)
- 性别
- All
入选标准
- •(1) Patients with pediatric congenital heart disease requiring life-sustaining cardiac repair surgery.
- •(2) Patients under 15 years of age (when consent is obtained from a substitute).
- •(3) Patients who need to undergo cardiac catheterization, cardiovascular angiography, and MSCT
- •angiography to determine the diagnosis and treatment plan.
- •(4) Patients scheduled to undergo surgery for congenital heart disease within 180 days of obtaining consent.
- •(5) Patients with the following congenital heart diseases in which the three-dimensional structure of the
- •heart and great vessels are extremely complicated.
- •1. Double outlet right ventricle
- •2. Complete transposition of the great arteries
- •3. Congenitally corrected transposition of the great arteries
- •4. Coarctation of aorta/ Interrupted aortic arch
- •5. Ventricular septal defect with multiple defects
- •6. Univentricular Heart (including complete atrioventricular septal defect with unbalanced ventricles)
- •7. Tetralogy of Fallot with or without pulmonary atresia
- •8. Hypoplastic left heart syndrome and its analogs
排除标准
- •(1) Critically ill patients who may require urgent cardiac repair surgery before the simulation using the ped
- •UT-Heart system is available.
- •(2) Patients who are allergic to contrast media used in MSCT and cardiac catheterization/angiography.
- •(3) Patients for whom follow-up until 30 days after surgery is difficult.
- •(4) Patients who are judged by the principal investigator to be unsuitable for participation in this study.
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