Repaired Tetralogy of Fallot Italian Registry

ConditionsTetralogy of Fallot Cardiac Death, Sudden Cardiac Arrhythmia Cardiac Event

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age10+

SponsorAzienda Ospedaliero, Universitaria Ospedali Riuniti

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with Repaired - TOF

Disqualifiers

Age < 10 years

Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein

Incomplete CMR exam

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Repaired Tetralogy of Fallot1 intervention

Trial outcomes

Primary outcomes

Cardiac death

Number of Participants with cardiac-releted death

Time frame

6 years

Secondary outcomes

Hospitalizations

Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

Time frame

6 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Lead sponsor

SICP WG CMR/CT

Collaborator

Fondazione Toscana Gabriele Monasterio