LifeCourse A Melbourne Children's Research Initiative

The Australian and New Zealand (ANZ) Fontan Registry (Fontan)

The Australian and New Zealand Fontan Registry is a population-based registry collecting health information on all patients who have undergone the Fontan procedure (used to treat single-ventricle congenital heart disease) living in Australia and New Zealand. It is the largest Fontan database in the world, providing researchers and doctors with information to help improve treatment options and long-term health outcomes for patients.

The aims of the Registry are to facilitate understanding of the changing composition and health outcomes of this cohort through population-based, longitudinal follow up; better delineate associations between short-term and long-term outcomes and modifiable factors; provide vital information for health service provision and planning; and enable recruitment for prospective, randomised trials.

Study Summary
Study name	The Australian and New Zealand (ANZ) Fontan Registry
Study abbreviation	Fontan
Current principal investigator/s	Yves d'Udekem
Current project manager	Carley Clendenning
Primary Institution/s	Murdoch Children’s Research Institute - MCRI
Collaborating Institution/s	All paediatric and adult congenital heart disease centres across Australia and New Zealand
Major funding source/s	National Health and Medical Research Council - NHMRC Heart Foundation HeartKids
Study website	https://www.fontanregistry.com/
Key reference for study	Iyengar, A.J., Winlaw, D.S., Galati, J.C., Gentles, T.L., Weintraub, R.G., Justo, R.N., Wheaton, G.R., Bullock, A., Celermajer, D.S. and d’Udekem, Y. (2014). The Australia and New Zealand Fontan Registry: description and initial results from the first population-based Fontan registry. Intern Med J, 44(2): 148-55. d’Udekem, Y., Iyengar, A.J., Galati, J.C., Forsdick, V., Weintraub, R.G., Wheaton, G.R., Bullock, A., Justo, R.N., Grigg, L.E., Sholler, G.F., Hope, S., Radford, D.J., Gentles, T.L., Celermajer, D.S. and Winlaw, D.S. (2014). Redefining expectations of long-term survival after the Fontan procedure: twenty-five years of follow-up from the entire population of Australia and New Zealand. Circulation, 130(11 Suppl 1): S32-8.
Study focus	The Fontan registry gathers information on health and wellbeing outcomes in individuals who have undergone Fontan surgery, used to treat single-ventricle congenital heart disease. This registry will help to improve long-term outcomes, treatment options and therapies for those who have undergone Fontan surgery.
Sampling frame	All individuals in Australia and New Zealand who have undergone the Fontan surgical procedure since it was first described in 1971.
Primary study type	Register
Primary participant (at recruitment)	Index child
Year commenced	2009
Is this study ongoing?	Yes - the study is ongoing
Ongoing recruitment?	Yes
Sample size (N)	1821 as of November 2021
Survey data available?	No
Imaging data available?	Yes
Linkage to administrative dataset/s?	Yes, linkage to (at least one) administrative dataset completed
Biosamples available?	No
Are data available to others outside study team, with appropriate safeguards and structures in line with the cohort’s ethics and governance processes?	Yes
Are there any costs associated with data/sample access for approved requests?	There are usually no costs associated with access
Broadest type of participant consent available	Extended consent (can be used for future ethically approved research related to this project)

Study Contacts
Principal investigator/s	Yves d'Udekem
Project manager	Carley Clendenning
Study Contact	Email: info@fontanregistry.com Address: Fontan Registry Murdoch Children's Research Institute, Royal Children’s Hospital Flemington Road, Parkville Victoria 3052 Australia