About this trial
Title:
Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach
Background:
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential.
Aim:
Assess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR.
Identify predictors of arrhythmia using strain and clinical parameters.
Methods:
Design: Prospective observational study over one year.
Population: Adults (≥18 years) with repaired TOF undergoing follow-up CMR.
Assessments:
Clinical evaluation (NYHA class)
Echocardiography (RV size, function, valve status)
Laboratory tests (BNP, NT-proBNP)
Exercise testing (METs, VO₂ max)
ECG \& 24-hour Holter monitoring (QRS duration, arrhythmias)
CMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV)
Outcomes:
Primary: Functional assessment of repaired TOF patients.
Secondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation).
Statistical Analysis:
Comparison between arrhythmic and non-arrhythmic groups.
Logistic regression for predictors of arrhythmia.
ROC analysis to determine optimal strain cut-off values.
Ethical Considerations:
Ethics committee approval and informed consent.
Data confidentiality maintained.
Eligibility criteria
Qualifiers
Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft).
Adults (age ≥18 years) with repaired TOF.
Undergoing routine CMR for clinical follow-up.
Sinus rhythm or known history of ventricular arrhythmia.
Disqualifiers
Confounding other congenital defects e.g. AV canal.
Significant aortic regurgitation or stenosis.
Significant mitral regurgitation.
Residual significant major aorto-pulmonary collaterals (MAPCAs).
Trial design
Treatments tested in this trial
- CMR, stress ECG, Holter, BnP