Repaired Tetralogy of Fallot Italian Registry (RETE-Fallot)

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Status: Enrolling

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

Treatments: Diagnostic Test: Cardiac magnetic resonance imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05288894

SICP WG CMR/CT 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with Repaired - TOF

Exclusion criteria

• Age < 10 years
• Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein
• Incomplete CMR exam

Trial design

150 participants in 1 patient group

Repaired Tetralogy of Fallot

Description:

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.

Treatment:

Diagnostic Test: Cardiac magnetic resonance imaging