Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

NCT ID: NCT05225311

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-22

Study Completion Date

2055-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ebstein Anomaly Tricuspid Valve Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia

Patients will be followed for life-long outcomes.

Observation

Intervention Type OTHER

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

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Lindsay Freud

Head of Fetal Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lindsay Freud, MD

Role: CONTACT

416-813-7500

Diana Balmer-Minnes, BSc

Role: CONTACT

416-813-7654 ext. 228624

Facility Contacts

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Diana Balmer-Minnes

Role: primary

4168137654 ext. 228624

Other Identifiers

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1000076991

Identifier Type: -

Identifier Source: org_study_id

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