RETE-Fallot: Repaired Tetralogy of Fallot Italian Registry

Sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti (Other)

Overall Status

Recruiting

CT.gov ID

NCT05288894

Collaborator

SICP WG CMR/CT (Other), Fondazione Toscana Gabriele Monasterio (Other)

150

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tetralogy of Fallot Cardiac Death, Sudden Cardiac Arrhythmia Cardiac Event	Diagnostic Test: Cardiac magnetic resonance imaging

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Cardiac death [6 years]
Number of Participants with cardiac-releted death

Secondary Outcome Measures

Hospitalizations [6 years]
Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCPC	Ancona	Marche	Italy	60123

Sponsors and Collaborators

Azienda Ospedaliero, Universitaria Ospedali Riuniti
SICP WG CMR/CT
Fondazione Toscana Gabriele Monasterio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Francesco Bianco, Medical Doctor, Azienda Ospedaliero, Universitaria Ospedali Riuniti

ClinicalTrials.gov Identifier:

NCT05288894

Other Study ID Numbers:

SICP WG CMR/CT 001

First Posted:

Mar 21, 2022

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Tetralogy of Fallot

Death, Sudden, Cardiac

Death

Death, Sudden

Study Results

No Results Posted as of Apr 1, 2022