NCT05225311

Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	Observation	Patients will be followed by the registry for life-long outcomes.

Timeline

• Start date: 2021-09-22
• Primary completion: 2050-09-01
• Completion: 2055-09-01
• First posted: 2022-02-04
• Last updated: 2025-05-31

Locations

1 site across 1 country: Canada