Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Transplantation-free survival
研究概览
简要总结
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.
The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.
详细描述
Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all echocardiographic examinations according to protocol. The growth of the left heart structures and the postnatal outcome will be compared between the intervention and non-intervention groups.
The decision whether a fetal balloon dilatation shall be attempted is not part of the study protocol. The number of examinations of mother/fetus/infant in this study is not different from the number of examinations that will be recommended for someone choosing not to be part of this study. Participation in the study does not affect the care and treatment mothers and fetuses are receiving during pregnancy, nor how the infant is examined and treated after birth.
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
- 23 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
- •Aortic valve stenosis with antegrade flow through the valve
- •Predominantly left-to-right shunt at the atrial level
- •Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
- •Qualitatively depressed left ventricular function
- •Left ventricular end-diastolic diameter Z-score > ±0
- •Left ventricular inlet length in diastole :
- •Gestational age ≤ 24+6: Z-score > ±0
- •Gestational age 25+0 to 27+6: Z-score > -0.75
- •Gestational age ≥ 28+0: Z-score > -1.50
- •Mitral valve diameter in diastole Z-score > -2.0
- •B. All of the following postnatal treatment options need to be available:
- •Surgical or catheter based aortic valvotomy
- •Ross-Konno surgery
- •Norwood or hybrid stage-one surgery
排除标准
- •Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
- •Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.
结局指标
主要结局
Transplantation-free survival
时间窗: Follow-up from study inclusion during fetal life until 2 years postnatal age
Transplantation-free survival from fetal diagnosis to 2 years postnatal age with a biventricular circulation without pulmonary hypertension at that time. Absence of pulmonary hypertension is defined as a TR max velocity ≤ 2.8 m/s with no other echocardiographic signs of pulmonary hypertension and/or catheter data showing a mean pulmonary arterial pressure \<25 mmHg.
次要结局
- Intervention-related fetal death(From the time of fetal intervention until 24 hours after the intervention)
- Maternal complications to fetal intervention procedure(From time of fetal intervention until 24 hours after the intervention)
- Preterm delivery(From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks)
- Fetal death not directly related to the intervention(From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.)
- Fetal left heart growth(From the date of study inclusion until just before the first postnatal catheter or surgical intervention, or death, whichever comes first, total time frame 7 months)
研究者
Mats Mellander
Associate professor, Consultant pediatric and fetal cardiology
Queen Silvia Children's Hospital, Gothenburg, Sweden