Cardiac Arrhythmia, Cardiac Death, Sudden, Cardiac Event, Tetralogy of Fallot
Conditions
Brief summary
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
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.
Interventions
A routine cardiac magnetic resonance imaging with biventricular function evaluation, atrial volumes, LGE acquisitions, and pulmonary and aortic assesment.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with Repaired - TOF
Exclusion criteria
* Age \< 10 years * Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein * Incomplete CMR exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 6 years | Number of Participants with cardiac-releted death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 6 years | Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure |
Countries
Italy