Rachel M Wald1, Mustafa A Altaha2, Nanette Alvarez3, Christopher A Caldarone4, Tiscar Cavallé-Garrido5, Frédéric Dallaire6, Christian Drolet7, Jasmine Grewal8, Camille L Hancock Friesen9, Derek G Human10, Edward Hickey4, Camilla Kayedpour11, Paul Khairy12, Adrienne H Kovacs11, Gerald Lebovic13, Brian W McCrindle14, Syed Najaf Nadeem15, David J Patton16, Andrew N Redington14, Candice K Silversides11, Edythe B Tham17, Judith Therrien18, Andrew E Warren19, Bernd J Wintersperger2, Isabelle F Vonder Muhll20, Michael E Farkouh11. 1. Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Medical Imaging, University Health Network, University of Toronto, Toronto, Ontario, Canada; Division of Pediatric Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. Electronic address: rachel.wald@uhn.ca. 2. Department of Medical Imaging, University Health Network, University of Toronto, Toronto, Ontario, Canada. 3. Adult Congenital Heart Disease Clinic, Division of Cardiovascular Diseases, Peter Lougheed Hospital, Calgary, Alberta, Canada. 4. Cardiovascular Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. 5. Pediatric Cardiology, Montreal Children's Hospital, McGill University, Montreal, Quebec, Canada. 6. Division of Pediatric Cardiology, University Hospital of Sherbrooke, University of Sherbrooke, Sherbrooke, Quebec, Canada. 7. Division of Pediatric and Congenital Cardiology, Department of Pediatrics, Laval University Hospital, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada. 8. Pacific Adult Congenital Heart Clinic, Division of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 9. Division of Cardiovascular Surgery, IWK Health Centre, Halifax, Nova Scotia, Canada. 10. Children's Heart Centre, Division of Cardiology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada. 11. Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada. 12. Adult Congenital Center, Montreal Heart Institute, Université de Montreal, Montreal, Quebec, Canada. 13. Applied Health Research Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. 14. Division of Pediatric Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. 15. Division of Cardiology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. 16. Pediatric Cardiology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada. 17. Pediatric Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada. 18. MAUDE Unit (McGill University Health Network/Beth Raby Adult Congenital Heart Disease Clinic, Jewish General Hospital), McGill University, Montreal, Quebec, Canada. 19. Division of Pediatric Cardiology, Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada. 20. Division of Cardiology, Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.
Abstract
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.
RCT Entities:
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.