Repaired Tetralogy of Fallot Italian Registry

Recruiting

• Conditions: Cardiac Event; Cardiac Death, Sudden; Tetralogy of Fallot; Cardiac Arrhythmia
• Interventions: Diagnostic Test: Cardiac magnetic resonance imaging

• Registration Number: NCT05288894
• Lead Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-12-31
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Repaired Tetralogy of Fallot	Cardiac magnetic resonance imaging	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.

Primary Outcome Measures

Name	Time	Method
Cardiac death	6 years	Number of Participants with cardiac-releted death

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	6 years	Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

Trial Locations

Locations (1)

CCPC; 🇮🇹 Ancona, Marche, Italy