International Fetal Cardiac Intervention Registry
Research type
Research Database
Full title
International Fetal Cardiac Intervention Registry
IRAS ID
120085
Contact name
Anita Moon-Grady
Contact email
Research summary
International Fetal Cardiac Intervention Registry
REC name
West of Scotland REC 4
REC reference
13/WS/0220
Date of REC Opinion
20 Nov 2013
REC opinion
Further Information Favourable Opinion
Data collection arrangements
This will be a retrospective and prospective
study of fetal echocardiograms undertaken in our institution at the Evelina Children's Hospital from 2000 present.
The
images will be reviewed in line with the protocol set out by the research team at the University of California, by a single
operator to reduce inter operator variability. Demographics from maternal, fetal cardiology and neonatal case notes will
be collected and echocardiographic measurements will be made from previouly recorded ultrasound studies. Chief
investigator and co investigator will review the data collected before submission. Information gathered will be
anonymous and entered into the secure web based REDCap international database, coordinated by the University of
Califormia, San Francisco.Research programme
Fetal aortic stenosis is an anatomically simple birth defect where there is partial blockage of the aortic valve limiting blood flow out the left side of the heart. If the blockage becomes severe in fetal life, the left heart structures may stop growing and the baby may be born with hypoplastic left heart syndrome (HLHS), a condition incompatible with life without high risk, newborn heart surgery. Postnatal outcomes remain guarded with the need for three major cardiac operations in early childhood. Attempts have been made to promote blood flow across the valve in utero, in the form of ballooning (aortic valvuloplasty). The first intervention was reported in 1989 and since then several international groups have attempted the procedure with some success (Kohl T, 2000). To date, clinical results of maternalfetal intervention are based on comparisons with historical controls and address efficacy rather than safety (McElhinney D 2009, Arzt W 2011). Careful study is required to study the natural history of the disease in untreated fetuses and ensure safe, properly performed trials are undertaken in the future.
Research database title
International Fetal Cardiac Intervention Registry
Establishment organisation
Fetal Cardiovascular Program, University of California
Establishment organisation address
The Fetal Treatment Center
505 Parnassus Avenue, Room M306, UCSF
San Francisco
CA, 94143