Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Canada
The Hospital for Sick Children
Recruiting
Toronto
Contact Information
Primary
Lindsay Freud, MD
lindsay.freud@sickkids.ca
416-813-7500
Backup
Diana Balmer-Minnes, BSc
diana.balmer-minnes@sickkids.ca
416-813-7654
Time Frame
Start Date: September 22, 2021
Estimated Completion Date: September 2055
Participants
Target number of participants: 1500
Treatments
Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia
Patients will be followed for life-long outcomes.
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov