Status:
RECRUITING
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
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Prevention of Venous Thromboembolism
Congenital Heart Disease
Eligibility:
All Genders
Up to 18 years
Brief Summary
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their do...
Eligibility Criteria
Inclusion
- 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
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization
- Previous treatment with rivaroxaban
Key Trial Info
Start Date :
June 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06193863
Start Date
June 18 2024
End Date
December 31 2026
Last Update
December 29 2025
Active Locations (1)
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1
Many Locations
Multiple Locations, Japan