Repaired Tetralogy of Fallot Italian Registry

NCT05288894 | Recruiting DMC

• 1 other identifier: SICP WG CMR/CT 001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cardiac death

  Number of Participants with cardiac-releted death

  6 years

Secondary Outcomes (1)

• Hospitalizations

  6 years

Study Arms (1)

Repaired Tetralogy of Fallot

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.

Diagnostic Test: Cardiac magnetic resonance imaging

Interventions

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.

Repaired Tetralogy of Fallot

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a repaired-TOF without associated complex pathology underwent CMR imaging.

You may qualify if:

• Patients with Repaired - TOF

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead
• SICP WG CMR/CT: collaborator
• Fondazione Toscana Gabriele Monasterio: collaborator

Study Sites (1)

CCPC

Ancona, The Marches, 60123, Italy

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Tetralogy of Fallot; Death, Sudden, Cardiac; Arrhythmias, Cardiac; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)