An observational study in Tetralogy of Fallot, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Observational
Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.
Participants with repaired tetralogy of Fallot (RTOF) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. Cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. There are different post-processing techniques published for measuring RV volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). The primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative RV volumetric thresholds for intervention. As a secondary aim, the investigators will determine the reproducibility of different contouring methods.
93 studies on the registry are indexed under Tetralogy of Fallot; 26 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 39 observational studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with repaired tetralogy of Fallot (RTOF) with chronic pulmonary regurgitation who require monitoring for right ventricular dilatation.
Exclusion Criteria:
Patients undergoing routine clinical aand CMR surveillance
Diagnostic Test: Cardiac MRI
For clinical surveillance
Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique
Measurements of indexed right ventricular end-diastolic volume will be repeated using different contouring techniques on the same cardiac MRI study performed at baseline pre-surgery.
Time frame: Cross-sectional study. Repeated measurements performed on the baseline CMR study.
Plan to share: No
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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust