Actively Recruiting

All Genders
NCT05225311

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

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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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Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry | DecenTrialz