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Clinical Trials in France / NCT07864129
Recruiting Observational

Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot

NCT07864129 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Observational
Started
2026-06-18
Last updated
2026-10-07

Condition(s) studied

Tetralogy of Fallot (TOF)Congenital Heart Defects

Study summary

Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery. The development of pulmonary arteries is a key determinant in surgical decision-making.

This multicenter retrospective observational study aims to evaluate the evolution of pulmonary artery dimensions using the Nakata index at key stages of patient management (birth, palliative surgery, and complete repair). The goal is to assess its predictive value in optimizing surgical strategy and improving outcomes in patients with Tetralogy of Fallot or pulmonary atresia with ventricular septal defect.

Eligibility

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged from birth to less than 18 years * Patients operated at Strasbourg or Bordeaux University Hospitals between 01/01/2010 and 31/12/2024 * Patient (or legal guardians) not opposing the reuse of medical data for research purposes Exclusion Criteria: * Patient expressing opposition to participation in the study * Parents/legal guardians or minor opposing data reuse * Specific clinical forms (VDDI) * Absence of subvalvular obstruction and absence of muscular resection

Primary outcome measure(s)

  • Nakata index evolution and predictive value — From birth to complete surgical repair (retrospective data 2010-2024)
    Assessment of the Nakata index based on pulmonary artery diameters measured on imaging at different time points (birth, palliative surgery, complete repair), and evaluation of its association with surgical outcomes using predefined thresholds (108 and 160 mm²/m²).

Trial sites (1)

FacilityCityRegionStatus
Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07864129 on ClinicalTrials.gov ↗ ← All trials in France