Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
The Hospital for Sick Children
1,500 participants
Sep 22, 2021
OBSERVATIONAL
Conditions
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. Despite the high mortality associated with severe EA/TVD in the fetus, it has only been studied retrospectively. By prospectively enrolling a cohort across multiple centers, many questions may be answered in the perinatal period and beyond. The registry will allow us to understand perinatal and postnatal decision-making in this complex group of patients across centers. Given the rarity of the disease, a retrospective arm was added to the original prospective study in May 2024.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- 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
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Interventions
Patients will be followed by the registry for life-long outcomes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05225311