Status:
RECRUITING
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Ebstein Anomaly
Tricuspid Valve Dysplasia
Eligibility:
All Genders
Brief Summary
Ebstein anomaly and tricuspid valve dysplasia (EA/TVD) are rare congenital tricuspid valve malformations that carry among the highest mortality of all congenital heart disease diagnosed in utero. Desp...
Eligibility Criteria
Inclusion
- Mothers of fetuses (ages 14-54) diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
- Mothers may be enrolled at any gestational age, up to the day of pregnancy outcome (elective termination of pregnancy, demise, or live-birth)
- Singletons, twins or higher order multiples may be included
- Consent obtained at a participating site
Exclusion
- Mothers of fetuses diagnosed with EA/TVD in the context of abnormal segmental anatomy (AV and/or VA discordance) or other lesions, such as congenitally corrected transposition of the great arteries or pulmonary atresia with intact ventricular septum
- Unable or unwilling to provide consent
Key Trial Info
Start Date :
September 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2055
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05225311
Start Date
September 22 2021
End Date
September 1 2055
Last Update
May 31 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8