title: Rationale and design of the Canadian Outcomes Registry Late After Tetralogy of Fallot Repair: the CORRELATE study.
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.
authors.affiliation: 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.
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Wald
authors.affiliation: Department of Medical Imaging, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Mustafa A
authors.initials: MA
authors.lastname: Altaha
authors.affiliation: Adult Congenital Heart Disease Clinic, Division of Cardiovascular Diseases, Peter Lougheed Hospital, Calgary, Alberta, Canada.
authors.forename: Nanette
authors.initials: N
authors.lastname: Alvarez
authors.affiliation: Cardiovascular Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Caldarone
authors.affiliation: Pediatric Cardiology, Montreal Children's Hospital, McGill University, Montreal, Quebec, Canada.
authors.forename: Tiscar
authors.initials: T
authors.lastname: Cavallé-Garrido
authors.affiliation: Division of Pediatric Cardiology, University Hospital of Sherbrooke, University of Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Dallaire
authors.affiliation: Division of Pediatric and Congenital Cardiology, Department of Pediatrics, Laval University Hospital, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada.
authors.forename: Christian
authors.initials: C
authors.lastname: Drolet
authors.affiliation: Pacific Adult Congenital Heart Clinic, Division of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Jasmine
authors.initials: J
authors.lastname: Grewal
authors.affiliation: Division of Cardiovascular Surgery, IWK Health Centre, Halifax, Nova Scotia, Canada.
authors.forename: Camille L
authors.initials: CL
authors.lastname: Hancock Friesen
authors.affiliation: Children's Heart Centre, Division of Cardiology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Derek G
authors.initials: DG
authors.lastname: Human
authors.affiliation: Cardiovascular Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Hickey
authors.affiliation: Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Camilla
authors.initials: C
authors.lastname: Kayedpour
authors.affiliation: Adult Congenital Center, Montreal Heart Institute, Université de Montreal, Montreal, Quebec, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Khairy
authors.affiliation: Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Adrienne H
authors.initials: AH
authors.lastname: Kovacs
authors.affiliation: 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.
authors.forename: Gerald
authors.initials: G
authors.lastname: Lebovic
authors.affiliation: Division of Pediatric Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Brian W
authors.initials: BW
authors.lastname: McCrindle
authors.affiliation: Division of Cardiology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.
authors.forename: Syed Najaf
authors.initials: SN
authors.lastname: Nadeem
authors.affiliation: Pediatric Cardiology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.
authors.forename: David J
authors.initials: DJ
authors.lastname: Patton
authors.affiliation: Division of Pediatric Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Redington
authors.affiliation: Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Candice K
authors.initials: CK
authors.lastname: Silversides
authors.affiliation: Pediatric Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada.
authors.forename: Edythe B
authors.initials: EB
authors.lastname: Tham
authors.affiliation: MAUDE Unit (McGill University Health Network/Beth Raby Adult Congenital Heart Disease Clinic, Jewish General Hospital), McGill University, Montreal, Quebec, Canada.
authors.forename: Judith
authors.initials: J
authors.lastname: Therrien
authors.affiliation: Division of Pediatric Cardiology, Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Warren
authors.affiliation: Department of Medical Imaging, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Bernd J
authors.initials: BJ
authors.lastname: Wintersperger
authors.affiliation: Division of Cardiology, Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.
authors.forename: Isabelle F
authors.initials: IF
authors.lastname: Vonder Muhll
authors.affiliation: Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Farkouh
mesh_terms: D000328:Adult; D002170:Canada / Q000453:epidemiology; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D011788:Quality of Life; D012042:Registries; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D013771:Tetralogy of Fallot / Q000601:surgery*; D013997:Time Factors; D016277:Ventricular Function, Left / Q000502:physiology*