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NCT Number: NCT05225311

Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

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.

Recruiting

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Key information

Conditions

Ebstein Anomaly Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tricuspid Valve Dysplasia

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location status: Recruiting

Location contact

Diana Balmer-Minnes

CONTACT

[email protected]

4168137654 ext. 228624

Lindsay Freud, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers of fetuses (ages 14-54) diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
  • Mothers may be enrolled at any gestational age, up to the day of pregnancy outcome (elective termination of pregnancy, demise, or live-birth)
  • Singletons, twins or higher order multiples may be included
  • Consent obtained at a participating site

Exclusion criteria

  • 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
  • Unable or unwilling to provide consent

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Proportion of fetuses who survive to live-birth at term

    Time frame: 37 0/7 to 40 0/7 weeks gestation

  2. Proportion of live-born children who survive to 30 days

    Time frame: 0-30 days

  3. Freedom from death beyond the neonatal period

    Time frame: 30 days-30 years

Secondary outcomes

  1. Change in umbilical artery pulsatility index throughout gestation

    Time frame: 20 0/7 to 40 0/7 weeks gestation

  2. Proportion with hydrops throughout gestation

    Time frame: 20 0/7 to 40 0/7 weeks

  3. Average gestational age at birth

    Time frame: At birth

  4. Average birth weight

    Time frame: At birth

  5. Proportion who undergo neonatal cardiac surgery

    Time frame: 0-30 days

  6. Freedom from cardiac re-intervention

    Time frame: 30 days-30 years

  7. Freedom from cardiac arrhythmia

    Time frame: 30 days-30 years

  8. Infant neurodevelopment as assessed by Bayley Scales of Infant Development

    Time frame: 12-15 months

  9. Pediatric neurodevelopment as assessed by Adaptive Behavior Assessment System

    Time frame: 3-18 years

  10. Quality of life as assessed by Peds QL General and Cardiac Modules

    Time frame: 2-30 years

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Balmer-Minnes, BSc

CONTACT

[email protected]

416-813-7654 ext. 228624

Lindsay Freud, MD

CONTACT

[email protected]

416-813-7500

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Acronym: FEAT Registry

Important dates

Study start
2021
Primary completion
2050
Study completion
2055
First posted
Feb 4, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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