Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Ebstein Anomaly Clinical Trial

— FEAT Registry  

Official title:

Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225311
• Other study ID #: 1000076991
• Status: Recruiting
• Start date: September 22, 2021
• Est. completion date: September 2055

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Lindsay Freud, MD
• Phone: 416-813-7500
• Email: lindsay.freud[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2055
• Est. primary completion date: September 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Ebstein Anomaly

Intervention

Other:
• Observation
Patients will be followed by the registry for life-long outcomes.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of fetuses who survive to live-birth at term		37 0/7 to 40 0/7 weeks gestation
Primary	Proportion of live-born children who survive to 30 days		0-30 days
Primary	Freedom from death beyond the neonatal period		30 days-30 years
Secondary	Change in umbilical artery pulsatility index throughout gestation		20 0/7 to 40 0/7 weeks gestation
Secondary	Proportion with hydrops throughout gestation		20 0/7 to 40 0/7 weeks
Secondary	Average gestational age at birth		At birth
Secondary	Average birth weight		At birth
Secondary	Proportion who undergo neonatal cardiac surgery		0-30 days
Secondary	Freedom from cardiac re-intervention		30 days-30 years
Secondary	Freedom from cardiac arrhythmia		30 days-30 years
Secondary	Infant neurodevelopment as assessed by Bayley Scales of Infant Development		12-15 months
Secondary	Pediatric neurodevelopment as assessed by Adaptive Behavior Assessment System		3-18 years
Secondary	Quality of life as assessed by Peds QL General and Cardiac Modules		2-30 years