Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061574) titled 'Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)' on May 15.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Medical University
Condition:
Condition - Patients who underwent right ventricular outflow tract reconstruction using Contegra artificial blood vessels during surgery for congenital heart disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to elucidate the long-term outcomes and prognostic factors associated with the use of Contegra artificial blood vessels in Japan.
This will aid in appropriate patient selection and the choice of surgical materials, thereby contributing to improved survival and quality of life for children with congenital heart disease.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key 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
Key exclusion criteria - Cases for which no postoperative follow-up was conducted
Cases in which the medical records are significantly incomplete and cannot be evaluated
Target Size - 300
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 10 Month 27 Day
Date of IRB - 2025 Year 12 Month 03 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070449
Disclaimer: Curated by HT Syndication.
