Congenital Heart Disease Clinical Trial
— FASSprospOfficial title:
Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Weeks to 31 Weeks |
Eligibility | Inclusion Criteria: 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): 1. Aortic valve stenosis with antegrade flow through the valve 2. Predominantly left-to-right shunt at the atrial level 3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels 4. Qualitatively depressed left ventricular function 5. Left ventricular end-diastolic diameter Z-score > ±0 6. Left ventricular inlet length in diastole : 1. Gestational age = 24+6: Z-score > ±0 2. Gestational age 25+0 to 27+6: Z-score > -0.75 3. Gestational age = 28+0: Z-score > -1.50 7. Mitral valve diameter in diastole Z-score > -2.0 B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery Exclusion Criteria: 1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta 2. 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Kinderherzzentrum Linz | Linz | |
Canada | The Hospital for Sick Children Toronto | Toronto | |
Finland | Department of Paediatric Cardiology, Helsinki University Children's Hospital | Helsinki | |
Germany | Pediatric Cardiology - University Hospital Bonn | Bonn | |
Germany | Department of Pediatric and Congenital Cardiology, University of Heidelberg | Heidelberg | |
Germany | University hospital Technical university, mother- and-child center | Munich | |
Poland | Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education. | Warsaw | |
Spain | Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre | Madrid | |
Sweden | Department of Pediatric Cardiology, Skane University Hospital | Lund | |
Sweden | Department of pediatric cardiology, Karolinska Institute | Stockholm | |
Sweden | Department of Pediatrics, Umeå University Hospital | Umeå | |
United States | Congenital Heart Collaborative, Nationwide Children's Hospital | Columbus | Ohio |
United States | Fetal Cardiovascular Program, University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Queen Silvia Children's Hospital, Gothenburg, Sweden | Sahlgrenska University Hospital, Sweden, Swedish Heart Lung Foundation |
United States, Austria, Canada, Finland, Germany, Poland, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transplantation-free survival | 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. | Follow-up from study inclusion during fetal life until 2 years postnatal age | |
Secondary | Intervention-related fetal death | Intervention-related fetal death (defined as fetal death within 24 hours of procedure) | From the time of fetal intervention until 24 hours after the intervention | |
Secondary | Fetal death not directly related to the intervention | Fetal death not directly related to the intervention, except termination of pregnancy | From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion. | |
Secondary | Maternal complications to fetal intervention procedure | Maternal complications to procedure requiring intensive care or resulting in maternal death | From time of fetal intervention until 24 hours after the intervention | |
Secondary | Preterm delivery | Preterm delivery before 37 weeks gestational age | From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks | |
Secondary | Fetal left heart growth | Fetal left heart growth as measured with dimensions expressed a z-scores of the mitral valve diameter, left ventricular inlet length and aortic valve diameter | 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 |
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