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Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

NCT05225311 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

  • Ebstein Anomaly
  • Tricuspid Valve Dysplasia

Interventions

OTHER

Observation

Patients will be followed by the registry for life-long outcomes.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2050-09-30
Completion
2055-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225311 on ClinicalTrials.gov