Actively Recruiting
Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum
Led by Hospital Universitario 12 de Octubre · Updated on 2025-09-15
150
Participants Needed
2
Research Sites
308 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario 12 de Octubre
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pulmonary atresia (PA)/critical stenosis (CS) with intact ventricular septum (PA/CS-IVS) is a rare congenital heart disease (CHD), that presents heterogeneously. Prognosis is conditioned by the possibility of achieving a primary repair with biventricular circulation (BV) or a one-and-a-half ventricle solution vs. a palliative approach bound to a univentricular (UV) circulation in which both survival and quality of life are significantly impaired. Predicting UV circulation prenatally is still a challenge. The aim of this study is: 1/ to evaluate the natural history of the disease and develop a prognostic model for the prediction of transplantation-free survival with a biventricular or a one-and-a-half repair at 2 years postnatal age 2/ To develop a model to predict the risk of right ventricle dependent coronary circulation 3/ To evaluate prenatal and postnatal outcomes in non-intervened fetuses with a confirmed postnatal diagnosis of PA-CS/IVS including Intrauterine death, neonatal/Infant death, number of required postnatal procedures, need for oxygen support, need for cardiac transplantation
CONDITIONS
Official Title
Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Absence of flow at the pulmonary valve or presence of thickened and domed pulmonary valve cusps with a pinhole jet of flow
- Doppler evidence of ductal-dependent pulmonary circulation
- Intact ventricular septum
You will not qualify if you...
- Poor imaging windows or incomplete/poor quality scan
- Termination of pregnancy
- Cases that undergo prenatal pulmonary valvuloplasty later in pregnancy
- Unconfirmed PA-CS/IVS at birth
- Functional PA-CS/IVS conditions such as Ebstein malformation or monochorionic twins
- Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery
- Significant extracardiac anomalies or known genetic syndromes affecting outcomes, including those diagnosed after birth
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
2
University of Gothenburg
Gothenburg, Sweden
Active, Not Recruiting
Research Team
C
Cecilia Villalain, MD PhD
CONTACT
A
Alberto Galindo, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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