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Clinical trial Recruiting at 1 site Observational

Registry for fetal Ebstein anomaly and tricuspid valve dysplasia

Official title: Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Run by The Hospital for Sick Children · NCT05225311 · Data updated 2026-11-12

This study is collecting information from mothers of unborn babies with Ebstein anomaly and tricuspid valve dysplasia to see how best to care for these serious heart conditions.

More Tricuspid Valve Disease trials

Quick facts

Study typeObservational
SexAll
Enrollment1500 (estimated)
SponsorThe Hospital for Sick Children
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedSeptember 22, 2021
Main results expectedSeptember 2050
Study endsSeptember 2055
Registry record updatedMay 31, 2025
Trial IDNCT05225311 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include mothers of fetuses diagnosed with Ebstein anomaly or tricuspid valve dysplasia at any gestational age.

Probably not a fit

Patients whose fetuses have EA/TVD in the context of abnormal segmental anatomy or other significant congenital heart defects may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to collect data on fetuses diagnosed with Ebstein anomaly and tricuspid valve dysplasia, which are serious congenital heart defects. By enrolling mothers of affected fetuses across multiple centers, the study seeks to gather prospective information on perinatal and postnatal decision-making. The goal is to better understand the outcomes and management strategies for these complex cases, which have historically been studied retrospectively. This observational approach will provide valuable insights into the care of these patients.

Why it matters

Potential benefit: If successful, this registry could improve understanding and management of fetal Ebstein anomaly and tricuspid valve dysplasia, potentially leading to better outcomes for affected infants.

How similar studies have gone: While there have been retrospective studies on EA/TVD, this prospective registry approach is novel and aims to fill gaps in existing knowledge.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • The Hospital for Sick Children
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.