Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorUniversity Hospital, Strasbourg, France
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Pediatric patients with Tetralogy of Fallot or related conditions managed surgically in tertiary care centers in Strasbourg and Bordeaux.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Nakata index evolution and predictive value
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).
Time frame
From birth to complete surgical repair (retrospective data 2010-2024)Sponsors and contacts
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Source ClinicalTrials.gov