FEAT Registry
Research type
Research Database
IRAS ID
314625
Contact name
Trisha Vigneswaran
Contact email
Research summary
FETAL EBSTEIN ANOMALY AND TRICUSPID VALVE DYSPLASIA (FEAT) REGISTRY
REC name
West of Scotland REC 4
REC reference
22/WS/0068
Date of REC Opinion
17 Jun 2022
REC opinion
Favourable Opinion
Data collection arrangements
This will be a prospective study of fetuses diagnosed with one of two conditions: 'Ebstein's anomaly of the tricuspid valve' or 'Tricuspid valve dysplasia'. Patients will be enrolled from fetal cardiac clinics in the UK. The type of data collected will include: medical data on the maternal health during pregnancy, fetal heart findings, the evolution of the condition through pregnancy, child's initial condition at birth and then subsequent assessments through childhood and into adulthood. The main type of data collected will be from the usual clinical care provided by their medical team. As part of the study it is important to relate outcomes to specific heart scan findings/measurements and this requires that anonymised scans images will be uploaded to a research database. If famililes are in agreement, additional questionaires regarding the child's development will be sent out. Only health professionals from your medical team will review your medical notes. Only anonymised data will be shared to the research Registry which is a secure web based REDCap international database, coordinated by the Hospital for Sick Kids, Toronto and University of Toronto, Canada. The Registry will be collecting anonymised data from > 30 hospitals around the world.
Research programme
Fetal Ebstein's anomaly of the tricuspid valve or tricuspid valve dysplasia can affect both the tricuspid valve and pulmonary valve function before and after birth. There is a spectrum with some babies only mildly affected after birth and others which may not survive pregnancy or beyond the first weeks after birth without specialist cardiac care. For some children, major heart surgery may be required in the first weeks after birth. Postnatal outomes are variable for this condition and it is not understood why some babies do well and others do not. There have been a number of research publications on this condition including a multicentre study from USA & Canda, however, this only collected retrospective data rather than information from the point of diagnosis. Furthermore, there are some variants of this condition which may benefit from in utero treatments, but this is also not well established and this Registry may help us to understand if properly performed clinical trials are required in the future. It is important to further our understanding of the natural history of this complex heart condition so that we can provide optimal treatments for affected babies.
Research database title
FETAL EBSTEIN ANOMALY AND TRICUSPID VALVE DYSPLASIA (FEAT) REGISTRY
Establishment organisation
The Hospital for Sick Children
Establishment organisation address
University of Toronto,
Toronto, Ontario
Canada
M5G 1X8