Repaired Tetralogy of Fallot Italian Registry

Study Overview
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Brief Summary
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The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

Detailed Description
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This is an observational prospective registry that will enroll patients presenting with repaired Tetralogy of Fallot (TOF) undergoing a cardiac magnetic resonance (CMR) imaging study in our recruiting CMR-Laboratories. CMR imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the Late Gadolinium Enhancement (LGE), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. We will also assess the aortic valve for regurgitation and measurement of the aortic size. At follow-up, any interventional or surgical procedures performed and symptoms or any major (Death) and cardiac (cardiac-related hospitalization) events will be collected.

Official Title
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Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot

Conditions
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Tetralogy of Fallot, Cardiac Death, Sudden, Cardiac Arrhythmia, Cardiac Event

Intervention / Treatment
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* Diagnostic Test: Cardiac magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Repaired - TOF Exclusion Criteria: Age < 10 years Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein Incomplete CMR exam

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repaired Tetralogy of Fallot<br>A patient affected by Tetralogy of Fallot (right ventricle outflow obstruction, right ventricle hypertrophy, ventricular septal defect, aortic overriding of the ventricular defect) that already underwent cardiac surgery for the correction. | Diagnostic Test: Cardiac magnetic resonance imaging<br>* A routine cardiac magnetic resonance imaging with biventricular function evaluation, atrial volumes, LGE acquisitions, and pulmonary and aortic assesment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | Number of Participants with cardiac-releted death | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure | 6 years |