Repaired Tetralogy of Fallot Italian Registry (RETE-Fallot)

April 15, 2024 updated by: Francesco Bianco, Azienda Ospedaliero, Universitaria Ospedali Riuniti

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 6 years
Number of Participants with cardiac-releted death
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: 6 years
Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Collaborators

Fondazione Toscana Gabriele Monasterio
SICP WG CMR/CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SICP WG CMR/CT 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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