Clinical ResearchRationale and Design of the Canadian Outcomes Registry Late After Tetralogy of Fallot Repair: The CORRELATE Study
Section snippets
Rationale
Optimal timing of PVR to address chronic important PR in the asymptomatic individual is considered one of the most important, but as yet unresolved, questions in contemporary CHD practice worldwide.16, 17 In the left heart, prospective cohort data were used to define an inflection point in the natural history of chronic asymptomatic clinically relevant aortic regurgitation, where risk of death exceeds the risk of surgery and the case for intervention is clearly made.18 In contrast to the wealth
Study design
The CORRELATE study is a multicentre, prospective cohort study involving 15 clinical centres in 8 Canadian cities. These sites encompass the largest pediatric cardiology and adult congenital cardiac programs in the country (Supplemental Fig. S1 and Supplementary Table S1 in the Supplementary Material). Candidates ≥ 12 years of age will be eligible for inclusion if ≥ moderate residual PR exists (regurgitation fraction ≥ 25% using CMR or flow reversal in the PAs on echocardiography) after TOF
Results
To the best of our knowledge, CORRELATE is the first large, prospective, multi-centre registry of children and adults after TOF repair to be established in North America.
Discussion
CORRELATE will assemble clinical, imaging, and functional data in a large, unselected, pan-Canadian cohort living with the sequelae of chronic PR after early TOF repair. Prospective enrollment will allow for ongoing, detailed analysis of clinical status, with specific focus on evaluation of symptoms and measurement of HR-QOL at various time points before and after PVR. We anticipate that candidates will be evaluated at regular intervals and we will ensure that relevant clinical outcomes are
Conclusions
CORRELATE is a pan-Canadian, multicentre, cohort study of children and adults with chronic PR after early TOF repair. CORRELATE will uniquely link clinical, imaging, and functional data to evaluate clinically relevant outcomes in those managed conservatively compared with those referred for PVR. Specific emphasis will be placed on the effect of PVR on clinical measures of well-being and adverse outcomes.
Funding Sources
The CORRELATE study is funded by the Canadian Institutes of Health Research (MOP 119353).
Disclosures
The authors have no conflicts of interest to disclose.
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These authors contributed equally to this work.