Actively Recruiting
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Led by The Hospital for Sick Children · Updated on 2025-05-31
1500
Participants Needed
1
Research Sites
1771 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers of fetuses aged 14 to 54 years diagnosed with Ebstein Anomaly or Tricuspid Valve Dysplasia of any severity with normal segmental anatomy (atrioventricular and ventriculoarterial concordance)
- Mothers may be enrolled at any gestational age, up to the day of pregnancy outcome (elective termination, fetal demise, or live birth)
- Singletons, twins, or higher order multiples may be included
- Consent obtained at a participating site
You will not qualify if you...
- Mothers of fetuses diagnosed with EA/TVD along with abnormal segmental anatomy (atrioventricular and/or ventriculoarterial discordance) or other heart defects such as congenitally corrected transposition of the great arteries or pulmonary atresia with intact ventricular septum
- Unable or unwilling to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
Research Team
L
Lindsay Freud, MD
CONTACT
D
Diana Balmer-Minnes, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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