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Repaired Tetralogy of Fallot Italian Registry

Recruiting
10 years of age
Both
Phase N/A

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Overview

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.

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.

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

Study details

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

NCT05288894

Azienda Ospedaliero, Universitaria Ospedali Riuniti

29 April 2024

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