Registry for fetal Ebstein anomaly and tricuspid valve dysplasia
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
The Hospital for Sick Children · NCT05225311
This study is collecting information from mothers of unborn babies with Ebstein anomaly and tricuspid valve dysplasia to see how best to care for these serious heart conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05225311 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect data on fetuses diagnosed with Ebstein anomaly and tricuspid valve dysplasia, which are serious congenital heart defects. By enrolling mothers of affected fetuses across multiple centers, the study seeks to gather prospective information on perinatal and postnatal decision-making. The goal is to better understand the outcomes and management strategies for these complex cases, which have historically been studied retrospectively. This observational approach will provide valuable insights into the care of these patients.
Who should consider this trial
Good fit: Ideal candidates include mothers of fetuses diagnosed with Ebstein anomaly or tricuspid valve dysplasia at any gestational age.
Not a fit: Patients whose fetuses have EA/TVD in the context of abnormal segmental anatomy or other significant congenital heart defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve understanding and management of fetal Ebstein anomaly and tricuspid valve dysplasia, potentially leading to better outcomes for affected infants.
How similar studies have performed: While there have been retrospective studies on EA/TVD, this prospective registry approach is novel and aims to fill gaps in existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Lindsay Freud, MD
- Email: lindsay.freud@sickkids.ca
- Phone: 416-813-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ebstein Anomaly, Tricuspid Valve Dysplasia