IFCIR
Research type
Research Database
IRAS ID
341474
Contact name
Trisha Vigneswaran
Contact email
Research summary
International Fetal Cardiac Intervention Registry (IFCIR)
REC name
West of Scotland REC 4
REC reference
24/WS/0034
Date of REC Opinion
14 Jun 2024
REC opinion
Favourable Opinion
Data collection arrangements
This is a retrospective and prospective study of fetal echocardiograms undertaken in our institution at the Evelina Children's Hospital from 2018 onwards. Two local investigators (Dr Trisha Vigneswaran & Professor John Simpson) will review cases where fetal cardiac intervention has been discussed or undertaken. In those patients who have consented for their anonymised data to be used, data will be submitted to the Registry. Demographics from maternal, fetal cardiology and paediatric case notes will be collected and echocardiographic measurements will be made from previouly recorded ultrasound studies according to the dataset protocol set out by the research team at the University of California San Francisco. The local investigators will review the data collected before submission. All 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
1. Fetal aortic stenosis is 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). 2. Fetal critical pulmonary valve stenosis/atresia is where there is a blockage of the pulmonary valve limiting blood flow. This can result in the equivalent of the HLHS but where the right ventricle is not formed. 3. HLHS with intact/restrictive atrial septum. With HLHS the atrial septum must be patent to allow blood from the lungs to pass back around the circulation. If the atrial septum becomes restrictive this leads to damage to the lungs and can render the children inoperable after birth. Careful study of these conditions and prenatal interventions are 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 (IFCIR)
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