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NCT Number: NCT05288894

Repaired Tetralogy of Fallot Italian Registry

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.

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Key information

Conditions

Tetralogy of Fallot Arrhythmias, Cardiac Cardiac Arrhythmia Cardiac Death, Sudden Cardiac Event Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Repaired - TOF

Exclusion criteria

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

Treatment and study plan

Cardiac magnetic resonance imaging

Diagnostic Test

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

Primary outcomes

  1. Cardiac death

    Time frame: 6 years

    Number of Participants with cardiac-releted death

Secondary outcomes

  1. Hospitalizations

    Time frame: 6 years

    Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Other

Collaborators

  • Fondazione Toscana Gabriele Monasterio
  • SICP WG CMR/CT

Registry information

Official study title

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

Acronym: RETE-Fallot

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 21, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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