An observational study in Tetralogy of Fallot, Cardiac Death, Sudden and Cardiac Arrhythmia, sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Recruiting at 1 site in Italy. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Observational
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.
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.
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 40 observational studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a repaired-TOF without associated complex pathology underwent CMR imaging.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Cardiac death
Number of Participants with cardiac-releted death
Time frame: 6 years
Hospitalizations
Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure
Time frame: 6 years
Plan to share: No
Started Mar 2021 (actual). Primary completion is estimated for Dec 2025, 57 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Azienda Ospedaliero, Universitaria Ospedali Riuniti