Predicting postnatal circulation in pulmonary atresia with intact ventricular septum

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international observational cohort that combines retrospective cases (2013–2023) with a prospective validation cohort to develop a prenatal prognostic model. Non-intervened fetuses diagnosed between 16+0 and 28+6 weeks with PA/CS-IVS will be included and baseline and follow-up fetal echocardiograms plus the first postnatal echo will be collected. All echocardiographic studies will be reviewed centrally by a core laboratory to confirm eligibility and standardize measurements. The primary outcome is transplantation-free survival with a biventricular or one-and-a-half repair at 2 years versus univentricular palliation or transplantation, and the study will also model risk of right-ventricle-dependent coronary circulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Absence of flow at the pulmonary valve (PA) 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.

Exclusion Criteria:

* Poor imaging windows and incomplete/poor quality scan
* Termination of pregnancy
* Cases initially included that undergo prenatal pulmonary valvuloplasty later on in pregnancy.
* Unconfirmed PA-CS/IVS at birth.
* Functional PA-CS/IVS (Ebstein malformation, monochorionic twins)
* Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery.
* Any significant (i.e that might influence outcome) extracardiac anomaly and/or known genetic syndromes. Also, if such a condition is present at inclusion but diagnosed only after birth, the case will be retrospectively excluded.

Where it's running

• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting
• University of Gothenburg
  Gothenburg, Sweden Active not recruiting

Study contacts

• Principal investigator: Cecilia Villalaín González, MD PhD — Instituto de investigación imas12
• Study coordinator: Cecilia Villalain, MD PhD
• Email: cecilia.villalain@salud.madrid.org
• Phone: +34913908310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.