Clinical trial NCT05288894: Repaired Tetralogy of Fallot Italian Registry
Official title: Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tetralogy of Fallot
Cardiac Death, Sudden
Cardiac Arrhythmia
Cardiac Event
Lead sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti
Sponsor class: OTHER
Collaborators: name: SICP WG CMR/CT
name: Fondazione Toscana Gabriele Monasterio
First posted: 2022-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a repaired-TOF without associated complex pathology underwent CMR imaging.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with Repaired - TOF

Exclusion Criteria:

* Age \< 10 years
* Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein
* Incomplete CMR exam

Primary outcomes:
measure: Cardiac death
timeFrame: 6 years
Secondary outcomes:
measure: Hospitalizations
timeFrame: 6 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: CCPC
state: Marche
Study officials:
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