NCT05288894

Repaired Tetralogy of Fallot Italian Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac magnetic resonance imaging	A routine cardiac magnetic resonance imaging with biventricular function evaluation, atrial volumes, LGE acquisitions, and pulmonary and aortic assesment.

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-12-31
• Completion: 2027-03-01
• First posted: 2022-03-21
• Last updated: 2024-04-16

Locations

1 site across 1 country: Italy