Ebstein AnomalyFEAT RegistryNCT05225311
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
An observational study of Ebstein Anomaly and Tricuspid Valve Dysplasia, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ebstein Anomaly, Tricuspid Valve Dysplasia
- What is being tested?
- Observation
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2021to Sep 2055
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Fetuses diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
Diana Balmer-Minnes, 4168137654 ext. 228624, diana.balmer-minnes@sickkids.ca
Lindsay Freud, MD
About this study
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
- Being tested
- Observation
- Medical subject headings
- Ebstein Anomaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Patients will be followed by the registry for life-long outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia | Patients will be followed for life-long outcomes. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of fetuses who survive to live-birth at term
Measured: 37 0/7 to 40 0/7 weeks gestation
Proportion of live-born children who survive to 30 days
Measured: 0-30 days
Freedom from death beyond the neonatal period
Measured: 30 days-30 years
Secondary outcomes (10)
Change in umbilical artery pulsatility index throughout gestation
Measured: 20 0/7 to 40 0/7 weeks gestation
Proportion with hydrops throughout gestation
Measured: 20 0/7 to 40 0/7 weeks
Average gestational age at birth
Measured: At birth
Average birth weight
Measured: At birth
Proportion who undergo neonatal cardiac surgery
Measured: 0-30 days
Freedom from cardiac re-intervention
Measured: 30 days-30 years
Freedom from cardiac arrhythmia
Measured: 30 days-30 years
Infant neurodevelopment as assessed by Bayley Scales of Infant Development
Measured: 12-15 months
Pediatric neurodevelopment as assessed by Adaptive Behavior Assessment System
Measured: 3-18 years
Quality of life as assessed by Peds QL General and Cardiac Modules
Measured: 2-30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start22 Sep 2021
- Primary completionSep 2050 (estimated)
- Study completionSep 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebstein AnomalyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Freud, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225311
- Sponsor's protocol ID
- 1000076991
- Acronym
- FEAT Registry
- Status last verified
- May 2025
- First submitted
- 6 Jan 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
- ClinicalTrials.gov ID
- NCT05225311
- Acronym / sponsor ID
- FEAT Registry / 1000076991
- Conditions
- Ebstein Anomaly, Tricuspid Valve Dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Sep 2050 (estimated)
- Study completion
- Sep 2055 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia | – | Other: ObservationPatients will be followed for life-long outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fetuses diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
Key inclusion criteria (4 listed)
- Mothers of fetuses (ages 14-54) diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
- Consent obtained at a participating site
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationPatients will be followed by the registry for life-long outcomes. | Other | Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia |
Primary outcome
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
10 secondary outcomes
Change in umbilical artery pulsatility index throughout gestation
Time frame: 20 0/7 to 40 0/7 weeks gestation
Proportion with hydrops throughout gestation
Time frame: 20 0/7 to 40 0/7 weeks
Average gestational age at birth
Time frame: At birth
Average birth weight
Time frame: At birth
Proportion who undergo neonatal cardiac surgery
Time frame: 0-30 days
Freedom from cardiac re-intervention
Time frame: 30 days-30 years
Freedom from cardiac arrhythmia
Time frame: 30 days-30 years
Infant neurodevelopment as assessed by Bayley Scales of Infant Development
Time frame: 12-15 months
Pediatric neurodevelopment as assessed by Adaptive Behavior Assessment System
Time frame: 3-18 years
Quality of life as assessed by Peds QL General and Cardiac Modules
Time frame: 2-30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebstein Anomaly and Tricuspid Valve Dysplasia, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Freud, MD (416-813-7500, lindsay.freud@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of fetuses who survive to live-birth at term (time frame: 37 0/7 to 40 0/7 weeks gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.