Rationale and Design of the Canadian Outcomes Registry Late After Tetralogy of Fallot Repair: The CORRELATE Study

Rachel M. Wald, Mustafa A. Altaha, Nanette Alvarez, Christopher A. Caldarone, Tiscar Cavallé-Garrido, Frédéric Dallaire, Christian Drolet, Jasmine Grewal, Camille L. Hancock Friesen, Derek G. Human, Edward Hickey, Camilla Kayedpour, Paul Khairy, Adrienne H. Kovacs, Gerald Lebovic, Brian W. McCrindle, Syed Najaf Nadeem, David J. Patton, Andrew N. Redington, Candice K. SilversidesEdythe B. Tham, Judith Therrien, Andrew E. Warren, Bernd J. Wintersperger, Isabelle F. Vonder Muhll, Michael E. Farkouh

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Background: Chronic hemodynamically relevant pulmonary regurgitation (PR) resulting in important right ventricular dilation and ventricular dysfunction is commonly seen after tetralogy of Fallot (TOF) repair. Late adverse clinical outcomes, including exercise intolerance, arrhythmias, heart failure and/or death accelerate in the third decade of life and are cause for considerable concern. Timing of pulmonary valve replacement (PVR) to address chronic PR is controversial, particularly in asymptomatic individuals, and effect of PVR on clinical measures has not been determined. Methods: Canadian Outcomes Registry Late After Tetralogy of Fallot Repair (CORRELATE) is a prospective, multicentre, Canada-wide cohort study. Candidates will be included if they are ≥ 12 years of age, have had surgically repaired TOF resulting in moderate or severe PR, and are able to undergo cardiovascular magnetic resonance imaging. Enrollment of > 1000 individuals from 15 participating centres (Toronto, Montreal, Quebec City, Sherbrooke, Halifax, Calgary, Edmonton, and Vancouver) is anticipated. Clinical data, health-related quality of life metrics, and adverse outcomes will be entered into a web-based database. A central core lab will analyze all cardiovascular magnetic resonance studies (PR severity, right ventricular volumes, and ventricular function). Major adverse outcomes (sustained ventricular tachycardia and cardiovascular cause of death) will be centrally adjudicated. Results: To the best of our knowledge, CORRELATE will be the first prospective pan-Canadian cohort study of congenital heart disease in children and adults. Conclusions: CORRELATE will uniquely link clinical, imaging, and functional data in those with repaired TOF and important PR, thereby enabling critical evaluation of clinically relevant outcomes in those managed conservatively compared with those referred for PVR.

Original languageEnglish (US)
Pages (from-to)1436-1443
Number of pages8
JournalCanadian Journal of Cardiology
Issue number11
StatePublished - Nov 1 2014
Externally publishedYes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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