Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)

Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study) - Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061574

Enrollment

300

Registered

2026-05-15

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who underwent right ventricular outflow tract reconstruction using Contegra artificial blood vessels during surgery for congenital heart disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients treated at facilities affiliated with the Japanese Society for Pediatric Cardiac Surgery that have performed 10 or more Contegra artificial vascular graft procedures between April 1, 2013, and December 31, 2024 No age restrictions

Exclusion criteria

Exclusion criteria: Cases for which no postoperative follow-up was conducted Cases in which the medical records are significantly incomplete and cannot be evaluated

Design outcomes

Primary

Measure	Time frame
Primary endpoint 1. Conduit durability (rate of avoidance of reintervention, rate of avoidance of insufficiency and stenosis) Continuous variables are presented as the median (interquartile range), and categorical variables as counts (proportions). Survival analysis will be performed using the Kaplan-Meier method, and comparisons between groups will be conducted using the log-rank test. Multivariate analysis will employ the Cox proportional hazards model to identify risk factors. Changes in ductal function over time will be analyzed using a mixed-effects model. Statistical significance is set at P < 0.05.	—

Measure

Time frame

Primary endpoint 1. Conduit durability (rate of avoidance of reintervention, rate of avoidance of insufficiency and stenosis) Continuous variables are presented as the median (interquartile range), and categorical variables as counts (proportions). Survival analysis will be performed using the Kaplan-Meier method, and comparisons between groups will be conducted using the log-rank test. Multivariate analysis will employ the Cox proportional hazards model to identify risk factors. Changes in ductal function over time will be analyzed using a mixed-effects model. Statistical significance is set at P < 0.05.

—

Secondary

Measure	Time frame
Secondary endpoints 1. Optimal patient size for 16-mm and 14-mm artificial vessels 2. Changes in annulus diameter over time (degree of expansion over time) 3. Incidence of infective endocarditis in the long term	—

Countries

Japan

Contacts

Public ContactAkinori Hirano

Saitama Medical University International Medical Center Pediatric Cardiovascular Surgery

hirano.akinori@gmail.com070-1799-3778

Outcome results