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Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum

NCT07095829 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-09-15

No results posted yet for this study

Summary

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

  • Pulmonary Atresia With Intact Ventricular Septum
  • Congenital Heart Disease
  • Fetal Cardiac Disorder

Interventions

OTHER

No intervention

Evaluation of natural history of the disease

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto de investigación Hospital 12 de Octubre

    collaborator UNKNOWN

  • Hospital Universitario 12 de Octubre

    lead OTHER

Principal Investigators

  • Cecilia Villalaín González, MD PhD · Instituto de investigación imas12

  • Alberto Galindo Izquierdo, MD PhD · Instituto de investigación imas12

Eligibility

Min Age
16 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2028-02-01
Completion
2029-12-31

Countries

  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095829 on ClinicalTrials.gov