An observational study in Aortic Coarctation, Retrospective Studies and Cohort Studies, sponsored by Institut Saint Pierre. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Institut Saint Pierre · Observational
Multicenter Retrospective Study Over a 14-Year Period From 2010 to 2024
Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers. From antenatal data to postoperative complications. Very large table.
Event-free survival (events: death, recoarctation, cardiac reinterventions, hypertension)
Description of patients who developed recoarctation Univariate and multivariate analysis of determinants of recoarctation (+/- death): patients with recoarctation versus others (excluding those who died without recoarctation).
Main Predictive Factors and Primary Criteria to Be Tested:
Antenatal diagnosis of coarctation: yes/no Prematurity: yes/no and subgroups (24-32 weeks vs. 32-37 weeks vs. term) Intrauterine growth restriction (IUGR): yes/no; IUGR vs. small for gestational age vs. normal weight Birth weight \< 2500 g vs. > 2500 g Prostaglandin infusion: yes/no Duration of prostaglandin infusion (days) Ventricular septal defect (VSD): yes/no Bicuspid aortic valve: yes/no Hemodynamic failure: yes/no Aortic valve size: \< -2 Z-score Horizontal aorta \< 3.6 mm vs. > 3.6 mm CT scan performed: yes/no Age at surgery: \< or > 1 month Surgical technique: patch vs. simple/extended Crafoord repair Associated procedure: yes/no Length of ICU stay (days) Postoperative cardiovascular complication: yes/no Postoperative isthmic peak velocity: \< or > 2 m/sec
Data Collection Excel database including 934 patients from 5 centers. 127 columns from A (Anonymization number) to DX (Date of hypertension diagnosis).
Primary endpoint: Prevalence and morbidity/mortality.
Data divided into 13 sections:
Sociodemographic data: Follow-up center, responsible physician Antenatal data: Follow-up and echocardiography results
Delivery:
Neonatal clinical presentation:
Diagnostic echocardiography:
Preoperative CT scan if performed:
First intervention:
Post-intervention echocardiography
Second intervention if performed:
Recoarctation with surgical intervention:
Recoarctation with catheter intervention Last follow-up data: Weight, height, blood pressure, date of last visit, last news Date of death
Exercise test results if available:
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 901 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Institut Saint Pierre is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers.
Inclusion Criteria: Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers.
Among associated intracardiac lesions, patients with ventricular septal defect (VSD), atrial septal defect (ASD), bicuspid aortic valve, and persistent left superior vena cava are also included.
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Exclusion Criteria: Children with complex congenital heart disease (e.g., transposition of the great arteries, double outlet right ventricle, single ventricle, truncus arteriosus, interrupted aortic arch) are excluded. Patients that underwent angioplasty as first intervention will also be excluded.
Prevalence of recoarctation after coarctation surgery
Prevalence of recoarctation among patients operated for aortic coarctation before one year of age. Recoarctation is defined by a cardiac catheterisme that showed a reduction of the lumen avec aortic isthmus of 50% and/or a peak-to-peak gradient \> 20mmHg at the level of the recoarctation. Survival analysis without recoarctation Percentage of patients and Kaplan-Meier survival curves.
Time frame: Up to 14 years post-surgery (2011-2025).
global survival in patient operated of coarctation
Proportion of patient that died (what ever the cause) after their surgery and during the follow up.
Time frame: 2011-2025 (14 years
Proportion of systemic hypertension at last follow up in patient operated of aortic coarctation
Regarding the systemic hypertension outcome, patients were classified as hypertensive at their last out-patient visit if they presented with diastolic and/or systolic blood pressure above the 95th percentile (according to sexe, age and height) or if they were under antihypertensive drugs To establish the onset date of systemic hypertension, outpatient cardiology visits were retrospectively reviewed from the most recent to the earliest encounter to identify: 1) the first abnormal blood pressure value and/or 2) the introduction of a hypertensive drugs.
Time frame: 2011-2015 (14 years)
Predictors of recoarctation
Outcomes associated to recoarctation will be assessed using univariate and multivariate logistic regression models. Variables considered include demographic, anatomical, and surgical characteristics (e.g., prematurity, birth weight, prostaglandin use, surgical technique). Comparisons will be made between patients who developed recoarctation and those who did not, excluding patients who died without recoarctation Analysis of potential predictive factors using univariate and multivariate models.
Time frame: Up to 14 years post-surgery
Plan to share: Yes — De-identified individual participant data including: Demographic characteristics (age, sex, birth weight, gestational age) Surgical details (type of repair, associated procedures) Follow-up outcomes (hypertension, recoarctation, cardiac reinterventions, mortality) Imaging results (echocardiography, CT scan if performed)
Supporting information: Statistical analysis plan
Time frame: IPD will be available after publication of the main results and for a period of 5 years.
Access criteria: No individual participant data will be shared
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in Jan 2026, 3 months.
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Institut Saint Pierre