Status:
UNKNOWN
Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
Lead Sponsor:
Barbara Burkhardt
Conditions:
Single-ventricle
Eligibility:
All Genders
Brief Summary
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directl...
Eligibility Criteria
Inclusion
- Patients of any age with functionally single ventricle (patients under age 8 who need anesthesia for CMR will not be actively recruited. They may be approached to participate only if the anesthesia and CMR examination have been planned independently for clinical purposes)
- Written informed consent
Exclusion
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, inability to give assent or consent, etc. of the participant and/or his/her parents or legal caregivers
- MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging (patient and guardians fill out a questionnaire).
- Pregnancy
- Participation in another study is not an exclusion criterion, e.g. in a therapeutic trial.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04017494
Start Date
September 1 2019
End Date
August 31 2023
Last Update
July 12 2019
Active Locations (1)
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1
University Children's Hospital Zürich, Switzerland
Zurich, Canton of Zurich, Switzerland, 8032