Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT05225311

Conditions

Ebstein Anomaly

Tricuspid Valve Dysplasia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Observation

Study Details

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.

Conditions

Ebstein Anomaly

Tricuspid Valve Dysplasia

Study ID

NCT05225311

Start date

Sep 22, 2021

Status verified date

May, 2025

Completion date

Sep, 2055

Anticipated

Primary completion date

Sep, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia

Patients will be followed for life-long outcomes.

Interventions

Observation

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

Primary outcome measure

  • Proportion of fetuses who survive to live-birth at term [ Time Frame: 37 0/7 to 40 0/7 weeks gestation ]
  • Proportion of live-born children who survive to 30 days [ Time Frame: 0-30 days ]
  • Freedom from death beyond the neonatal period [ Time Frame: 30 days-30 years ]

Central Contacts and Locations

Central contacts

Lindsay Freud, MD

416-813-7500lindsay.freud@sickkids.ca

Diana Balmer-Minnes, BSc

416-813-7654diana.balmer-minnes@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

Diana Balmer-Minnes

4168137654diana.balmer-minnes@sickkids.ca

Principal Investigator:

Lindsay Freud, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 31, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-05-31.