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Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry (FEAT Registry)

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ClinicalTrials.gov Identifier: NCT05225311
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Lindsay Freud, The Hospital for Sick Children

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Ebstein Anomaly Tricuspid Valve Dysplasia Other: Observation

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : September 2050
Estimated Study Completion Date : September 2055

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Fetal Ebstein's Anomaly or Tricuspid Valve Dysplasia
Patients will be followed for life-long outcomes.
 Other: Observation
Patients will be followed by the registry for life-long outcomes.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fetuses diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05225311


Contacts
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Contact: Lindsay Freud, MD 416-813-7500 lindsay.freud@sickkids.ca
Contact: Diana Balmer-Minnes, BSc 416-813-7654 ext 228624 diana.balmer-minnes@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Diana Balmer-Minnes    4168137654 ext 228624    diana.balmer-minnes@sickkids.ca   
Principal Investigator: Lindsay Freud, MD         
Sponsors and Collaborators
The Hospital for Sick Children
More Information
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Responsible Party: Lindsay Freud, Associate Professor; Pediatric and Fetal Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT05225311    
Other Study ID Numbers: 1000076991
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ebstein Anomaly
Congenital Abnormalities
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases