Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Launched by THE HOSPITAL FOR SICK CHILDREN · Jan 25, 2022

Keywords

ClinConnect Summary

The Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry is a clinical trial aimed at understanding two rare heart conditions—Ebstein anomaly and tricuspid valve dysplasia—found in unborn babies. These conditions can cause serious health issues, and unfortunately, they are associated with a high risk of mortality. The goal of this trial is to gather information from mothers and their babies to help doctors make better decisions during pregnancy and after birth. By enrolling participants from different medical centers, researchers hope to answer important questions about care for these complex heart conditions.

To be eligible for this study, mothers must have a fetus diagnosed with either Ebstein anomaly or tricuspid valve dysplasia, regardless of how severe the condition is. They can join the trial at any stage of their pregnancy and may have single babies, twins, or more. However, if the fetus has other heart problems or the mother cannot give consent, they will not be able to participate. Participants can expect to provide information about their pregnancy and the health of their baby, which will help shape future medical care for other families facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Mothers of fetuses (ages 14-54) diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
• • 1. Mothers may be enrolled at any gestational age, up to the day of pregnancy outcome (elective termination of pregnancy, demise, or live-birth)
• • 2. Singletons, twins or higher order multiples may be included
• • 2. Consent obtained at a participating site
• Exclusion Criteria:
• • 1. 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
• • 2. Unable or unwilling to provide consent