An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

Launched by BAYER · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called rivaroxaban in children with congenital heart disease who have undergone a specific heart surgery known as the Fontan procedure. The Fontan procedure helps improve blood flow but can increase the risk of blood clots, which can be very serious. Rivaroxaban is used to help prevent these clots, but it is important to understand how it affects children's health, especially regarding bleeding risks.

To participate in this study, children must be under 18 years old, have congenital heart disease, and have had the Fontan procedure. They must also be receiving rivaroxaban as part of their routine care. The researchers will gather information from medical records or through interviews during regular check-ups, without requiring any extra visits or tests. This study will run from December 2023 to June 2026, and researchers will observe participants for up to 30 days after they stop taking the medication or for a maximum of 2 years. The goal is to learn more about how often children experience serious bleeding or other bleeding issues while on rivaroxaban.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients under the age of 18 years
• • Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice
• • Informed consent form obtained from a legal representative
• Exclusion Criteria:
• • Participation in an investigational program with interventions outside of routine clinical practice
• • Contraindications according to the local marketing authorization
• • Previous treatment with rivaroxaban