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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05288894
Acronym
RETE-Fallot
Enrollment
150
Registered
2022-03-21
Start date
2021-03-01
Completion date
2027-03-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DIAGNOSTIC_TESTCardiac magnetic resonance imaging

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

Sponsors

SICP WG CMR/CT
CollaboratorUNKNOWN
Fondazione Toscana Gabriele Monasterio
CollaboratorOTHER
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with Repaired - TOF

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac death6 yearsNumber of Participants with cardiac-releted death

Secondary

MeasureTime frameDescription
Hospitalizations6 yearsRate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026