NCT05225311 Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
| NCT ID | NCT05225311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Ebstein Anomaly |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2021-09-22 |
| Primary Completion | 2050-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2021-09-22 with a primary completion date of 2050-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05225311 clinical trial?
This trial is open to participants of all sexes, studying Ebstein Anomaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05225311 currently recruiting?
Yes, NCT05225311 is actively recruiting participants. Contact the research team at lindsay.freud@sickkids.ca for enrollment information.
Where is the NCT05225311 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05225311 clinical trial?
NCT05225311 is sponsored by The Hospital for Sick Children. The trial plans to enroll 1,500 participants.