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NCT07864129
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Conditions: Tetralogy of Fallot (TOF), Congenital Heart Defects
Sex: All
Ages: 0 Years – 18 Years
Healthy volunteers: No
Enrollment: 400
Sponsor: University Hospital, Strasbourg, France
Location: Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg
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 Criteria
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
Source: ClinicalTrials.gov (NCT07864129). StuddyBuddy aggregates publicly available trial information.